BEUDAMED
    FDA Registration Active 🇺🇸 United States

    EXEL INC. DBA DHL SUPPLY CHAIN (USA)

    Reg #: 3008868758 · FEI: 3008868758 · Expires 2026
    View on FDA
    Products
    131
    Proprietary Names
    792
    Establishment Types
    1
    Classifications
    131

    Registration Details

    Registration Name
    EXEL INC. DBA DHL SUPPLY CHAIN (USA)
    Registration Number
    3008868758
    FEI Number
    3008868758
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    9440 South State Road 39, Suite 200
    City
    Mooresville
    State
    IN
    ZIP
    46158
    Country
    US

    Regulatory Submissions

    510(k) Number
    K123362
    PMA Number
    P830055

    Owner / Operator

    Firm Name
    Exel Inc. dba DHL Supply Chain (USA)
    Operator Number
    10026656
    Address
    360 Westar Blvd, Dept 555
    City
    Westerville
    State
    OH
    Postal Code
    43082
    Country
    US
    Correspondent
    John Kropczynski

    Products

    Device Name Product Code
    Screw, Fixation, Bone HWC
    Fastener, Fixation, Biodegradable, Soft Tissue MAI
    Pin, Fixation, Smooth HTY
    Rod, Fixation, Intramedullary And Accessories HSB
    Thoracolumbosacral Pedicle Screw System NKB
    Appliance, Fixation, Spinal Interlaminal KWP
    Orthosis, Spinal Pedicle Fixation MNI
    Orthosis, Spondylolisthesis Spinal Fixation MNH
    Appliance, Fixation, Spinal Intervertebral Body KWQ
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
    Fastener, Fixation, Nondegradable, Soft Tissue MBI
    Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite LXT
    Filler, Bone Void, Calcium Compound MQV
    Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation OIS
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive OIY
    Plate, Bone JEY
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
    Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented KWY
    Prosthesis, Hip, Hemi-, Femoral, Metal KWL
    Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate MEH
    Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece ERL
    Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
    Drill, Bone, Powered DZI
    Instrument, Surgical, Sonic And Accessory/Attachment JDX
    Drills, Burrs, Trephines & Accessories (Simple, Powered) HBE
    Cover, Burr Hole GXR
    Fastener, Plate, Cranioplasty HBW
    Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component KTT
    Plate, Fixation, Bone HRS
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Spinal Vertebral Body Replacement Device MQP
    Prosthesis, Condyle, Mandibular, Temporary NEI
    External Mandibular Fixator And/Or Distractor MQN
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
    Arthroscope HRX
    Plate, Cranioplasty, Preformed, Non-Alterable GXN
    Screw, Fixation, Intraosseous DZL
    Nail, Fixation, Bone JDS
    Monitor, Pressure, Intracompartmental LXC
    Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile GAQ
    Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer KWZ
    Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer HSN
    Syringe, Piston FMF
    Sacroiliac Joint Fixation OUR
    Staple, Fixation, Bone JDR
    Stimulator, Nerve ETN
    Neurosurgical Nerve Locator PDQ
    Bone Cement, Posterior Screw Augmentation PML
    Plate, Cranioplasty, Preformed, Alterable GWO
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWS
    Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented HSD
    Posterior Cervical Screw System NKG
    Orthosis, Spine, Plate, Laminoplasty, Metal NQW
    Cerclage, Fixation JDQ
    Condylar Plate Fixation Implant JDP
    Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented KWT
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented MBF
    Intervertebral Fusion Device With Integrated Fixation, Cervical OVE
    Orthopedic Stereotaxic Instrument OLO
    Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer KRO
    Neurological Stereotaxic Instrument HAW
    Intervertebral Fusion Device With Integrated Fixation, Lumbar OVD
    Mesh, Surgical FTM
    Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed PAJ
    Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery OXH
    Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon OWY
    Mesh, Surgical, Collagen, Thoracic, Chest Wall Reconstruction OXB
    Mesh, Surgical, Collagen, Staple Line Reinforcement OXE
    Pin, Fixation, Threaded JDW
    Cover, Shoe, Operating-Room FXP
    Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer HRY
    Prosthesis, Elbow, Semi-Constrained, Cemented JDB
    Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer HSX
    Shoulder Prosthesis, Reverse Configuration PHX
    Cement, Bone, Vertebroplasty NDN
    Cranial Distraction System PBJ
    Washer, Bolt Nut HTN
    Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer KRR
    Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer NPJ
    Prosthesis, Finger, Constrained, Polymer KYJ
    Suture, Nonabsorbable, Synthetic, Polyethylene GAT
    Suture, Surgical, Absorbable, Polydioxanone NEW
    Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis OSH
    Cement Obturator LZN
    Prosthesis, Elbow, Hemi-, Radial, Polymer KWI
    Appliance, Fixation, Nail/Blade/Plate Combination, Single Component KTW
    Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer MBH
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented LWJ
    Suture, Absorbable, Synthetic, Polyglycolic Acid GAM
    Suture, Nonabsorbable, Synthetic, Polyester GAS
    Bur, Surgical, General & Plastic Surgery GFF
    Blade, Saw, General & Plastic Surgery, Surgical GFA
    Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment HSZ
    Reamer HTO
    Prosthesis, Hip, Hemi-, Femoral, Metal Ball LZY
    Accessory, Surgical Apparel LYU
    Accessories, Arthroscopic NBH
    Implant, Fixation Device, Spinal JDN
    Intervertebral Fusion Device With Bone Graft, Cervical ODP
    Mesh, Surgical, Metal EZX
    Methyl Methacrylate For Cranioplasty GXP
    Driver, Wire, And Bone Drill, Manual DZJ
    Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) KWA
    Anchor, Suture, Bone Fixation, Metallic NOV
    System, Facet Screw Spinal Device MRW
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing NJL
    Retractor, Self-Retaining, For Neurosurgery GZT
    Growing Rod System PGM
    Sterilization Wrap Containers, Trays, Cassettes & Other Accessories KCT
    Component, Traction, Invasive JEC
    Mesh, Surgical, Acetabular, Hip, Prosthesis JDJ
    Bone Cement LOD
    Lamp, Operating-Room FQP
    Prosthesis, Rib Replacement MDI
    Software For Diagnosis/Treatment OSN
    Drills, Burrs, Trephines & Accessories (Manual) HBG
    Device, Fixation, Proximal Femoral, Implant JDO
    Rasp HTR
    Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Composite KYK
    Dress, Surgical FYE
    Motor, Drill, Pneumatic HBB
    Laparoscope, General & Plastic Surgery GCJ
    Nasopharyngoscope (Flexible Or Rigid) EOB
    Light, Surgical, Instrument FSQ
    Knee Arthroplasty Implantation System OOG
    Prosthesis, Hip, Cement Restrictor JDK
    Light Source, Fiberoptic, Routine FCW
    Retention Device, Suture KGS
    Brace, Drill HXY

    Proprietary Names

    MILAGRO ADVANCE INTERFERENCE SCREW K133520 SYNTHES (USA) ELASTIC INTRAMEDULLARY NAIL (EIN) END CAP, LINE EXTENSION MODIFICATION TO SYNTHES MATRIX SYSTEM SIDE EFFECT WITH HAND CONTROLS, HOOK ELECTRODE WITH HAND CONTROLS, 2.3 WEDGE ELECTRODE WITH HAND CONTROLS, S90 WITH HAND ORTHOGENESIS LPS HEALIX Ti ANCHOR with DYNACORD SYNTHES SIMPLE SMALL EXTERNAL FIXATOR (SSEF) NORIAN DRILLABLE ATTUNE (TM) KNEE SYSTEM - CRUCIATE RETAINING AOX POLY FIXED BEARING (FORMERLY PROJECT BLUE BOOK PBB)) -TRADITIONAL SYNTHES DUAL-OPENING USS; K020517 1.3 & 1.5MM CONTOURABLE TITANIUM (TI.) MESH PLATES Corail AMT Hip Prosthesis - Line Extension 2 DELTA CERAMIC FEMORAL HEAD (SPECIAL) Sonic surgical instrument and accessories/attachments SYNTHES (USA) RAPID RESORBABLE CRANIAL CLAMP DYNAMIC HIP SCREW SYNTHES CERVIFIX/ AXON; K023675 SYNTHES STERILE 2.7 MM RECONSTRUCTION PLATES COUGAR LS 15 LATERAL CAGE SYSTEM VAPR 2.3MM WEDGE ELECTRODE FOR USE WITH VAPR SYSTEM SYNTHES (USA) CLAVICLE HOOK PLATES MODIFICATION TO SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM SYNTHES MINI LENGTHENING APPARATUS DARWIN KNEE SYSTEM (TC3=TOTAL CONDYLAR 3) (PFC SIGMA) SYNTHES 3.5MM TITANIUM LCP PROXIMAL TIBIA PLATES VISION AML HIP PROSTHESES SYNTHES OC FUSION SYSTEM; K053418 GRIPTION TF 5.5MM STERILE LOCKING SCREWS Arthroscopic clearance K102298 SYNTHES PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANT SYNTHES 1.3 MM SELF-DRILLING SCREW K183506/ Healix Advance Anchor with Dynacord Suture INTRAFIX PEEK TAPERED SCREW MITEK ROTATOR CUFF QUICKANCHOR PLUS MODIFICATION TO THE SYNTHES (USA) UNIVERSAL SPINAL HOOK ROD AND AND SACRAL SCREW FIXATION SYSTEM IN 316L STAINLESS STE; SYNTHES (USA) CANNULATED TITANIUM HUMERAL NAIL SYSTEM SYNTHES (USA) COMPARTMENTAL PRESSURE MONITORING SYSTEM CLICK'X; K992739 SYNTHES MULTILOC PROXIMAL HUMERAL NAILING SYSTEM Milagro / Milagro Advance Interference Screw SYNTHES (USA) LATERAL ENTRY FEMORAL NAIL SYSTEM SYNTHES (USA) TITANIUM WIRE ATTUNE (TM) MEDIALIZED DOME &* MEDIALIZED ANATOMIC PATELLAE {TRADITIONAL} AOX 510(k) clearance HEALIX ANCHOR BIOCRYL RAPIDE INTERFERENCE SCREW MODIFICATIONS TO EXPEDIUM SPINE SYSTEM PINNACLE CONSTRAINED ACETABULAR LINER - LARGER SIZES TRANSFERRED-AGILITY LP TOTAL ANKLE PROSTHESIS - POLY TIBIAL INSERT DESIGN MODIFICATION SMF STAINLESS STEEL BONE SCREWS SYNTHES (USA) CHRONOS; K043045 K160856 SYNTHES 6.5 MM CANNULATED SCREW PANALOK QUICKANCHOR PLUS, PANALOK RC QUICKANCHOR PLUS DUAL SUTURE, PANALOK ANCHOR DePuy Spine_K173526 CONFIDENCE High Viscosity Spinal Cement, VIPER and EXPEDIUM Fenestrated Screw Systems PFC MODULAR PLUS OFFSET TIBIAL TRAY SYNTHES MATRIXNEURO CRANIAL PLATING SYSTEM CERAMIC FEMORAL HEAD (DELTA) SPECIAL 510(K) SYNTHES USS CLICK'X USS VAS DUAL-OPENING USS AND SMALL STATURE USS; K022949 EXPEDIUM SPINE SYSTEM CONCORDE BULLET SPINAL SYSTEM PFC SIGMA INSET PATELLA FOCUS TOTAL HIP SYSTEM AND FEMORAL HEADS FMS SHAVER BLADES AND BURRS MODIFICATION TO VBR SPINAL SYSTEM TRANSFERRED-GLOBAL AP SHOULDER SYSTEM (TRADITIONAL) [ VIPER SYSTEMS SYNTHES (USA) RETROGRADE/ANTEGRADE FEMORAL NAIL SYSTEM SYNTHES LOW PROFILE NEURO SYSTEM - 3 MM SCREWS DePuy Spine_K192014 ORTHOMESH SYNTHES AFS; K032534 SYNTHES USS CONNECTOR; K120571 BIOKNOTLESS AND LUPINE PLUS ANCHORS SYNTHES TITANIUM MULTI-VECTOR DISTRACTOR SYNTHES (USA) 1.5MM HEADLESS COMPRESSION SCREWS SYNTHES TRANSLATING MAXILLARY DISTRACTOR SYNTHES MATRIX SYSTEM; K100634 Healix BR Anchor, Healix PEEK Anchor, Healix Transtend, Gryphon T And P BR Anchor, Gryphon PEEK Anchor, VersaLok Anchor, DePuy Synthes 2.4mm LCP Straight Wrist Plate, Sterile SYNTHES (USA) RAPID RESORBABLE FIXATION SYSTEM EXPEDIUM MIS SPINE SYSTEM SYNTHES (USA) ELASTIC INTRAMEDULLARY NAIL (EIN) SYSTEM (LINE EXTENSION) SYNTHES MANDIBLE EXTERNAL FIXATOR S-ROM LF FEMORAL HEAD INNOVASIVE DEVICES INTRATUNNEL TIBIAL FIXATION FASTENER Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle Positioning Pins SYNTHES (USA) CURVILINEAR DISTRACTION SYSTEM SYNTHES VECTRA-ONE SYSTEM; K071667 SYNTHES (USA) UNIV. SCREW FIXATION SYSTEM (TITANIUM); K951794 TRANSFERRED-GLOBAL FX SHOULDER -SPECIAL 510(K) SYNTHES MATRIXORTHOGNATHIS FIXATION SYSTEM DEPUY PULSE LUMBAR CAGE SYSTEM Symphony OCT System- Additional Components MONARCH SPINE SYSTEM SYNTHES 4.5 MM AND 6.5 MM HEADLESS COMPRESSION SCREWS SYNTHES STERNAL FIXATION SYSTEM TRANSFERRED-GLOBAL FX POROUS COATED HUMERAL STEM SYNTHES PROXIMAL TIBIA PLATING SYSTEM TRAUMAFIX (TM) EXTERNAL FIXATOR K152539 SYNTHES (U.S.A.) UNIVERSAL SACRAL SYSTEM; K963045 SUMIT OCT SPINAL SYSTEM AND MOUNTAINEER OCT SPINAL SYSTEM VIPER SYSTEM USS ILIOSACRAL USS POLYAXIAL; K082572 NOILES ROTATING HINGE KNEE SYNTHES ZERO-P; K112459 DEPUY ACROMED VBR SYSTEM SYNTHES 4.5 MM VA-LCP CURVED CONDYLAR SYSTEM MODIFICATION TO EXPEDIUM SPINE SYSTEM TRANSFERRED-GLOBAL ADVANTAGE SHOULDER (SPECIAL 510(K)) DePuy Synthes T-PAL Ti Spacer; K151276 SYNTHES LARGE FRAGMENT DYNAMIC COMPRESSION LOCKING (DCL) SYSTEM K201661 SYMPHONY Navigation Ready Instruments and Universal Navigation Adaptor Set MITEK MINI ANCHOR, MODIFICATION SYNTHES STERILE 3.5 MM AND 4 MM CANNULATED SCREWS MODFICATION TO: EXPEDIUM SPINE SYSTEM FMS INTERMEDIARY TUBING AND STERILE ZONE KIT DePuy Synthes Variable Angle Locking Patella Plating System UNIVERSAL FEMORAL NAIL LPS DISTAL FEMORAL COMPONENT (TRADITIONAL) SYNTHES (USA) TOMOFIX MEDIAL DISTAL FEMUR PLATES S-ROM NOILES MARK 3 KNEE CAS HIP INSTRUMENTATION SYNTHES (USA) IMF SCREWS SYNTHES LCP PROXIMAL TIBIA PLATE SYNFIX-LR SPACER; K072253 VAPR 2.3MM END EFFECT ELECTRODE FOR USE WITH VAPR SYSTEM HEALIX ADVANCE SP PEEK Anchor TRANSFERRED-GLOBAL AP HUMERAL STEM W/ POROCOAT (TRADITIONAL) K091499 PINNACLE Dual Mobility RIGIDFIX BIOCRYL 2.7MM BTB (210815), FEMORAL 3.3MM ST (210816), AND TIBIAL 3.3MM ST (210817) CROSS PIN KITS HEALIX ADVANCE SP BIOCOMPOSITE Anchors LPS PROXIMAL TIBIAL COMPONENT (SPECIAL) SYNTHES MEDIUM EXTERNAL FIXATION SYSTEM-MR SAFE SYNTHES SACRAL BAR SYSTEM; K001720 STERILE VIEW KNEE-HIGH BOOTS AND DEPUY SHOE BOOTS SYNTHES LOCKING RECONSTRUCTION PLATE (LRP) WITH CONDYLAR HEAD VISION SOLUTION HIP PROSTHESES TITANIUM MOSS MIAMI SPINAL SYSTEM VERSALOK PEEK ANCHOR WITH ORTHOCORD SUTURE, MODELS 210818, 210819 TRANSFERRED-GAS PLASMA STERILIZATION SYNTHES STERILE LOW PROFILE NEURO CONTOURABLE MESH PLATES SYNTHES 4MM TITANIUM (TI.) LOCKING SCREWS ORACLE SPACER OPAL SPACER; K072791 SYNTHES RIB FIXATION SYSTEM Delta Xtend Alternate Angle 510(k) SYNTHES ANTERIOR TENSION BAND (ATB) SYSTEM; K022791 HEALIX ADVANCE Anchor with DYNACORD Suture MITEK BONE ANCHOR, MODIFICATION SYNTHES TI-15 MO LOCKING DISTAL RADIUS PLATING SYSTEM SYNTHES LOCKING HAND PLATES OSSE-LIGN DEPUY MOTECH MOSS-MIAMI SPINAL SYSTEM DURALOC ACETABULAR CUP LINERS (CROSS-LINKED POLYETHYLENE)(MARATHON) TRANSFERRED-DEPUY GLOBAL UNITE PLATFORM SHOULDER SYSTEM Elite Nitinol Fixation System SYNTHES LCP DIAPHYSEAL-METAPHYSEAL (DIA-META) VOLAR DISTAL RADIUS PLATES BOWTI ANTERIOR BUTTRESS STAPLE SYSTEM SYNTHES (USA) MEDIUM EXTERNAL FIXATION SYSTEM MOUNTAINEER OCT SPINAL SYSTEM MODIFICATION TO PINNACLE CONSTRAINED ACETABULAR LARGE 40/44 I.D. ESC LINERS (SPECIAL) [ULTAMET XL - FOR USE W/M SPEC HEA ANATOMIC MODULAR KNEE (AMK) CONGRUENCY POSTERIOR STABILIZED TIBIAL INSERT SYNTHES 2.4 MM UNIVERSAL LOCKING PLATE SYSTEM CONFIDENCE HIGH VISCOSITY BONE CEMENT Clearance Letter K201321 SYNTHES (USA) DISTAL FEMUR PLATE (DFP) SYSTEM SYNTHES LCP DISTAL TIBIA PLATES Craniomaxillofacial Distraction System (CMFD) 2.7MM LCP ULNA OSTEOTOMY SYSTEM UNIVERSAL GRIPTION TF {TITANIUM FOAM} CONES (KNEES), GRIPTION TF ACETABULAR AUGMENT (HIP) SYSTEM [TRADITIONAL] DEPUY C-STEM AMT (SPECIAL) (AMT= ARTICUL/EZE MINI TAPER) SYNTHES ANTERIOR CSLP SYSTEM; K030866 TITANIUM CANNULATED TIBIAL NAIL (TI CTN) SYNTHES PATIENT SPECIFIC PLATE MODIFIED SYNATOMIC VARIABLE FIT TIBIAL PLATEAU HEALIX TI ANCHOR MATRIXNEURO PREFORMED MESH (PART OF THE MATRIXNEURO CRANIAL PLATING SYSTEM) VIPER PRIME navigated inserter ARIZONA CONDYLAR TIBIAL PLATEAU VAPR P50 SUCTION ELECTRODE VAPR S90 SUCTION ELECTRODE VAPR P50 SUCTION ELECTRODE WITH HANDCONTROLS VAPRS90 SUCTION ELECT SYNTHES STERNAL ZIPFIX SYSTEM X-TREME ARTHROSCOPIC PUMP AND SHAVER SYSTEM SONGER CABLE SYSTEM SPIKED WASHER SYNTHES TOMOFIX OSTEOTOMY SYSTEM DEPUY FEMORAL HEADS (S-ROM ZIRCONIA / ZIRCONIA ARTICULEZE) SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEM SYNTHES CRANIOFACIAL PLATE AND SCREW SYSTEM VIPER PRIME Screws with Fenestrations HEALIX ADVANCE BR ANCHORS, HEALIX ADVANCE PEEK ANCHORS SYNTHES 6.5MM MIDFOOT FUSION BOLT SIGMA HIGH PERFORMANCE PARTIAL KNEE SYSTEM [PREVIOUSLY CALLED & CLEARED UNDER - GCK (GRADUATED COMPARTMENTAL KNEE)] S-ROM FEMORAL HIP STEM TRANSFERRED-(NEUFLEX) FINGER JOINT PROSTHESIS (MCP) SYNTHES SPINE PEDIATRIC ROD SYSTEM; K980761 SYNTHES 2.7/3.5MM VARIABLE ANGLE LCP ANKLE TRAUMA SYSTEM-ANTEROLATERAL DISTAL TIBIA PLATE MITEK THRADED ANCHOR (MTA) PINNACLE ACETABULAR ALTRX CUP LINERS (TRADITIONAL) [NON METAL ON METAL BEARING ALTERNATIVE] (ALTRALINK TM PROCESS) Small Size Orthocord Suture CEMENT RESTRICTORS ELITE MODULAR HIP SYSTEM (THACKRAY) -{ALSO SEE LIST OF PNS IN K940743-RANDA) RC LOOP /DUAL ORTHOCORD SUTURE,RC LOOP W/ETHIBOND SUTURE,RC LOOP W/PANACRYL SUTURE SYNTHES (USA) UNIV SPINE ROD/SACRAL SCREW FIX SYST; K930891 SYNTHES TITANIUM DIASTAL FEMORAL NAIL (TI DFN) SYSTEM SYNTHES MATRIXMANDIBLE SUBCONDYLAR PLATES DARWIN KNEE SYSTEM (PFC SIGMA) (CRUCIATE SUBSTITUTING) POROUS COATED AND NON-POROUS COATED EXPEDIUM, VIPER. VIPER 2 SPINE SYSTEM SYNTHES (USA) LARGE FRAGMENT LOCKING COMPRESSION PLATE (LCP) SYSTEM-T PLATE SYNTHES CERVIFIX SYSTEM; K011969 SYNTHES TITANIUM EXTERNAL FIXATOR CLAMPS (TI EFC) SFX SNAP-FIT CROSS CONNECTOR CHANGE IN PACKAGING OF UHMWPE COMPONENTS TRANSFERRED-GLOBAL ADVANTAGE EXTENDED HUMERAL HEAD MATRIXWAVE MMF SYSTEM EXPEDIUM SPINE SYSTEM 5.5MM COMMERICALLY PURE TITANIUM SPINAL RODS SYNTHES ANGULAR STABLE LOCKING SYSTEM (ASLS) ANGLED BLADE PLATE SYNTHES 9USA) ALVEOLAR RIDGE DISTRACTOR SYNTHES (USA) ELBOW HINGE FIXATOR LPS - MATERIAL CHANGETO K003182 (TRADITIONAL) 3.5 MM LCP DISTAL HUMERUS SYSTEM TRANSFERRED-MODIFIED NEUFLEX PIP FINGER Attune Shelf Life Extension 5 - 8 years SUMMIT BASIC PRESS-FIT HIP STEMS (SPECIAL 510(K)) MODIFICATION TO SYNTHES CERVIFIX SYSTEM; K030377 MODIFICATION TO: BIOKNOTLESS BR ANCHOR / LUPINE BR ANCHOR SIGMA KNEE PROSTHESIS FEMORAL ADAPTER (MODIFICATION TO K950010) [SPECIAL] CI HIP INSTRUMENTS (SPECIAL) SYNTHES CERVIFIX SYSTEM; K001864 SYNTHES 3.9 MM PELVIC SCREWS Synthes Sterile Drill Bits VIPER SYSTEM, EXPEDIUM SYSTEM HAND REAMERS NOILES CRUCIATE RETAINING KNEE (S-ROM) DePuy Synthes Hammertoe Continuous Compression Implant CONTROL CABLE SYSTEM K191943 SYMPHONY Navigation Ready Instruments, Universal Navigation Adaptor Set (UNAS) Summit Hip System SYNTHES 2.7 MM CANNULATED SCREW AND THREADED WASHER SYNTHES LCP PROXIMAL TIBIA PLATES LINE EXTENSION MODIFICATION TO VIPER SPINE SYSTEM EXPEDIUM SPINE SYSTEM, VIPER SYSTEM, VIPER 2 SYSTEM SYNTHES 3.5 MM LOW PROFILE PELVIC RECONSTRUCTION PLATE FEMORAL INTRAFIX SCREW AND SHEATH SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM (MEDICAL AND POSTEROLATERAL DISTAL HUMERUS PLATES) PM Change - Pinnacle HA - DePuy Ireland MITEK SUPER QUICKANCHOR, MODIFICATION SYNTHES 1/1.2 MM PLUSDRIVE SCREWS SYNTHES STERILE MANDIBLE EXTERNAL FIXATION KIT EXPEDIUM 4.5MM SPINE SYSTEM SYNFIX Evolution Secured Spacer System; K150673 SYNTHES RECONSTRUCTIVE PLATES 'Y' PLATES VEPER SYSTEM, EXPEDIUM SYSTEM FASTIN RC ANCHOR SYNTHES (USA) TIBIAL NAIL SYSTEM EX SYNTHES ZERO-P; K093762 Summit Hip Stems - Cork HA2 SYNTHES PEDIATRIC ROD SYSTEM; K991552 S-ROM 135 FEMORAL STEM & COLLAR (PART OF THE S-ROM TOTAL HIP SYSTEM) SYNTHES (USA) LCP DYNAMIC HELICAL HIP SYSTEM REPEL LITE CUT RESISTENT GLOVE LINERS ISOLA TANDEM CONNECTOR ORTHOCORD SUTURE SYNTHES (USA) RIA SYSTEM - EXPANDED INDICATIONS SYNTHES SPINE POSTERIOR CERVICAL/THORACIC HOOK/ROD SYSTEM; K980358 SYNTHES 2.7 MM/3.5 MM LCP DISTAL FIBULA PLATES HEX BUTTON SPA POROUS COATED PROXIMAL SLEEVES (TRADITIONAL) MODIFICATION TO SYNTHES (USA) TROCHANTER STABILIZATION PLATE (TSB) FOR DHS (LINE EXTENSION) LCS FEMORAL HIP PROSTHESIS SYNTHES RIA SYSTEM (EXPANDED INDICATIONS) Speed Triad ENDURANCE ALL POLY CEMENTED CUP ATTUNE Revision LPS Insert SYNTHES 6 COCR AND CPT TI-3 RODS; K103287 NORIAN SRS BONE VOID FILLER SYNTHES (USA) [SYNTHES] MINI EXTERNAL FIXATOR CANNULATED FEMORAL NAIL SKYLINE ANTERIOR CERVICAL PLATE SYSTEM, UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM, UNIPLATE 2 ANTERIOR CERVICAL PLATE SYST GRYPHON BR ANCHORS WITH PERMACORD UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM SYNTHES (USA) 3.5MM LCP PERIARTICULAR PROXIMAL HUMERUS PLATES MODIFICATION TO:SYNTHES (USA) TITANIUM WIRE K202472 - ACTIS Hip Prosthesis - Special 510(k) SYNTHES 7/7.3 MM CANNULATED SCREWS MEDIVISION ARTHROSCOPE ATTUNE PS [POSTERIOR STABILIZED] KNEE SYSTEM W/ AOX INSERTS (TRADITIONAL) SYNTHES (USA) [SYNTHES] MMFS - 2 MM SAGITTAL SPLIT PLATES ORTRON 90 HIP PROSTHESIS SYNTHES (U.S.A.) UNIVERSAL SPINAL PARALLEL CONNECTOR; K962608 ENDURANCE CALCAR HIP PROSTHESIS SYNTHES (USA) LCP MODULAR FOOT PLATES SYNTHES LCP PROXIMAL HUMERUS PLATES LATARJET CORTICAL SCREW SET TRUESPAN Meniscal Repair System SYNTHES (USA) 2.4 MM VA-LCP TWO COLUMN VOLAR DISTAL RADIUS PLATES RIGIDFIX SOFT TISSUE ACL CROSSPIN SYSTEM DePuy Spine_K173787 SYNTHES 4 MM ADJUSTABLE CLAMP FOR DISTAL RADIUS FIXATOR-MR SAFE Global Unite Platform Shoulder System Short Stem SYNTHES (USA) [SYNTHES} PERI-PROSTHETIC SCREWS VAPR TC ELECTRODE FOR USE WITH VAPR II ELECTROSURGICAL SYSTEM SYNTHES (USA) CHRONOS SYNTHES MATRIXMANDIBLE PREFORMED RECONSTRUCTION PLATES SYNTHES MATRIXMADIBLE PLATE AND SCREW SYSTEM SMALL FRAGMENT DYNAMIC COMPRESSION LOCKING (DCL) SYSTEM HEALIX Ti Dual Threaded Suture Anchor with DYNATAPE Suture RIGIDLOOP ADJUSTABLE CORTICAL FIXATION SYSTEM MITEK MINI QUICKANCHOR PLUS MODIFIED PROFILE FEMORAL HIP (CEMENTRALIZER) SYNTHES 90 DEGREE SCREWDRIVER PINNACLE ACETAB SYS. -MINOR TOLERANCE ADJUSTMNTS TO METAL SHELL & LINER PKG INSERT REVIS. S-ROM STD STEM (SPECIAL) MITEK MICRO QUICKANCHOR LPS UNIVERSAL HINGE INSERT ASSEMBLY {ASSEMBLY = *HINGE POST & *POLY BEARING} (TRADITIONAL) SYNTHES SYNAPSE TRANSCONNECTOR; K090549 SIGMA HIGH PERFORMANCE PARTIAL KNEE SYSTEM (PREVIOUSLY CALLED: UNITY KNEE RESURFACING SYS. & PRIOR TO THAT CALLED GCK) [ ATTUNE KNEE SYSTEM - CEMENTLESS CR & PS FEMORAL COMPONENTS SYNTHES 5/7.3 MM CANNULATED LOCKING SCREWS DePuy Synthes TFNA Augmentation System DePuy Synthes T-PAL Spacer System; K181231 MODULAR FOOT SYSTEM - 2.7 MM MODULE NEW JERSEY MODULAR FEMORAL HIP ESL MARATHON +4 POLYETHYLENE LINERS FOR PINNACLE ACETABULAR CUP SYSTEM (TRADITIONAL) SYNTHES SYNCAGE EVOLUTION SPACER; K122639 SYNTHES EXTERNAL MIDFACE DISTRACTOR SDB CERCLAGE SYSTEM DEPUY SPINE BENGAL, CONCORDE, COUGAR, DEVEX AND LEOPARD SYSTEMS SYNTHES ANTERIOR CSLP SYSTEM; K000742 TRANSFERRED-GLOBAL UNITE SHOULDER SYSTEM (ANATOMIC EPIPHYSEAL BODIES & 2 SMALLER HUMERAL HEADS)- TRADITIONAL NORIAN REINFORCED, NORIAN REINFORCED FAST SET PUTTY SYNTHES LOW PROFILE NEURO SYSTEM VIPER F2 FACET FIXATION SYSTEM PINNACLE ALTRX ACETABULAR LINERS -ADD'L SIZES (SPECIAL -EXTENSION TO K072963) SYNTHES CERCLAGE POSITIONING PIN SYNTHES 2.4 MM CANNULATED COMPRESSION SCREW SYNTHES NAVIGABLE PEDICLE PREPARATION INSTRUMENTS SYNTHES SPINE SMALL STATURE ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEM SYNTHES EXTERNAL FIXATION DEVICES, MR CONDITIONAL BLUE ORTHOCORD SUTURE SYNTHES(U.S.A.) ANTERIOR SPINAL PLATE SYNTHES ANTEROLATERAL CALCANEAL PLATE TRANSFERRED-GLOBAL AP CTA HEAD (SPECIAL TO K000575) MICRO QA+ ANCHOR WITH #3-0 ORTHOCORD SUTURE, MODEL 212843, MICROFIX AQ+ ANCHOR WITH #3-0 ORTHOCORD SUTURE SYNTHES 4.5 MM TITANIUM LCP PROXIMAL TIBIA PLATING SYSTEM SYNTHES LCP PEDIATRIC PLATE SYSTEMS SYNAPSE SYSTEM 4MM, OC FUSION SYSTEM 4MM TRUMATCH - 2D3D WITH 2.5 BLOCKS MatrixRIB Fixation System SYNTHES CURVILINEAR DISTRACTION SYSTEM TRANSFERRED-GLOBAL CAP CTA RESURFACING SHOULDER (CTA=CUFF TEAR ARTHROPATHY) MITEK FASTIN RC ANCHOR SYNTHES(USA)TITANIUM LOCKING PLATE SYSTEM(TILPS); K970048 MODULAR M HEADS MODIFICATION TO THE ARTICUL/EZE FEM HEADS(SPECIAL) [ULTAMET XL] C-STEM AMT (SPECIAL) (AMT= ARTICUL/EZE MINI TAPER) SMALL STATURE USS; K994121 OMNISPAN MENISCAL REPAIR SYSTEM SYNTHES STERILE 4.5 MM CANNULATED SCREWS K201336 SYNTHES CHRONOS COMPOSITE; K071046 MILAGRO INTERFERENCE SCREW K201346 SYNTHES CERVIFIX SYSTEM; K991089 SYNTHES (USA) VARIABLE ANGLE-LOCKING COMPRESSION PLATE (VA-LCP) DISTAL RADIUS SYSTEM SYNTHES MODULAR FOOT SYSTEM SYNTHES SPINE CERVIFIX SYSTEM SYNTHES DORSAL DISTAL RADIUS PLATE (DDRP) SYSTEM SYNTHES XRL; K103320 SYNTHES 2.4 MM CANNULATED SCREW VOLAR DISTAL RADIUS PLATE SYNTHES (USA) MODULAR MINI FRAGMENT LCP SYSTEM HEALIX TI ANCHORS SYNTHES PANGEA MONOAXIAL SYSTEM; K052151 CONCORDE Bullet Spinal System SYNTHES (USA) 2.4 MM LCP WRIST PLATE SYNTHES (USA) RATCHETING DISTRACTOR SYNTHES (USA) EXTERNAL FIXATION COMPONENT LINE EXTENSION - MR SAFE SYNTHES ANATOMICAL LOCKING PLATE SYSTEM RIGIDFIX CURVE ST ACL PLA CROSS PIN SYSTEM, RIGIDFIX CURVE ST ACL PEEK CROSS PIN SYSTEM TRI-LOCK BONE PRESERVATION STEM (BPS) (SPECIAL) PANALOK LOOP ANCHOR DYNACORD Suture SUMMIT ACETABULAR SYSTEM (SHELLS, LINERS, SCREWS AND APICAL PLUG) CAS KNEE INSTRUMENTATION (TRADITIONAL) PFC MODULAR TOTAL KNEE SYSTEM, MODUALR "PLUS" TIBIAL TRAY AND WEDGES ORTHOCORD #2-0 SUTURE WITH OR WITHOUT NEEDLES SMF TITANIUM (TI) ALLOY BONE SCREWS ULTIMA CEMENTED LONG STEM FEMORAL COMPONENT SYNTHES USS; K111358 GRYPHON BR ANCHOR W/PROKNOT TECHNOLOGY,GRYPHON PEEK ANCHOR W/ PROKNOT TECHNOLOGY PINNACLE ACETABULAR SYS. (PREVIOUSLY SUMMIT) VAPR VUE RADIOFREQUECY SYSTEM WITH ELECTRODES TRANSFERRED-AGILITY LP TOTAL ANKLE PROSTHESIS (FORMERLY ALVINE) -SPECIAL SPOTLIGHT ACCESS SYSTEM MODIFICATION TO:LATARJET CORTICAL SCREW SET, MODELS 523JT, 523J (36-48MM) SYNTHES CRANIAL PLATES SYNTHES (USA) SYNTHES MMFS-ADJUSTABLE SAGITTAL SPLIT PLATE SYNTHES CURVED RECONSTRUCTION PLATE HEALIX ADVANCE KNOTLESS PEEK ANCHOR (6.5MM) EXPEDIUM ANTERIOR SPINE SYSTEM RIGIDLOOP CORTICAL FIXATION SYSTEM SYNTHES (USA) LOCKING CONDYLAR PLATE (LCP) SYSTEM SYNTHES REPROCESSED EXTERNAL FIXATION DEVICES K200791 Navigation Enabled Instruments (NavLock) K170306 ISOLA AND EXPEDIUM GROWING SPINE SYSTEMS SYNTHES (USA) 5MM/7.3MM CRIMP POSITIONING PINS K171284 SYNTHES MULTILOC HUMERAL NAILING SYSTEM VIPER SPINE SYSTEM DePuy Synthes Sterilization Container System SYNTHES ADOLESCENT LATERAL ENTRY FEMORAL NAIL SYSTEM SYNTHES MATRIX MIS RODS; K093668 SYNTHES SMALL COBINATION CLAMP-MR SAFE SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM SYNTHES (USA) 2ND GENERATION PELVIC C-CLAMP SYNTHES MANDIBULAR MODULAR FIXATION SYSTEM SYNTHES STERILE 3 MM CANNULATED SCREW AND THREADED WASHER PFC CERAMIC HIP HEAD LPS METAPHYSEAL SLEEVE (TRADITIONAL) X-MESH EXPANDABLE CAGE SYSTEM DePuy Synthes Cortex, Cannulated, and Compression Screws K161616 EXPEDIUM Spine System/Synapse System; K142460 SYNTHES (USA) 1.5MM MINI FRAGMENT LCP SYSTEM SYNTHES 3.5MM LOW PROFILE CORTICAL SCREW PFC SIGMA CRUCIATE RETAINING KNEE SYSTEM (SIZE 1.5) [PRIOR NAME DARWIN] VERTEBRAL SPACER; K011037 DePuy Spine_K171439 SYNTHES (USA) STERILE STERNAL FIXATION SYSTEM SYNTHES (USA) 2.4/2.7 MM LOCKING FOOT MODULE SOLUTION SYSTEM HIP PROSTHESIS (SPECIAL-MATERIAL CHANGE) VIPER PRIME additions to the VIPER System VIPER 2 SYSTEM MAXILLARY DISTRACTOR SYNTHES 7.3 MM CANNULATED SLIPPED CAPITAL FEMORAL EPIPHYSIS SCREWS (SCFE) SYNTHES (USA) 3.5 AND 4.5 MM LOCKING COMPRESSION PLATE SYSTEM WITH EXPANDED INDICATIONS Clearance Letter Special 510(k) K203414 LPS DIAPHYSEAL & METAPHYSEAL SLEEVES SYNTHES CERVIFIX SYSTEM; K994187 SYNTHES (USA) 3.5 MM BROAD LCP & 4.5 MM LCP DISTAL HUMERUS PLATES DEPUY ADVANTAGE FIXATION SCREW SYSTEM MITEK ELECTROSURGICAL SYSTEM FOR ARTHROSCOPIC USE SYNTHES TITANIUM (TI) ALLOY HIGH TIBIAL OSTEOTOMY (HTO) SYSTEM SUMMIT DUOFIX HIP PROSTHESIS ADJUSTABLE LARGE FIXATOR SYSTEM PANALOK RC QUICKANCHOR PLUS, MODEL 212130, 212730; DUAL SUTURE PANALOK RC QUICKANCHOR PLLUS, MODELS 212132, 212732 SYNTHES LARGE EXTERNAL FIXATION, MR CONDITIONAL Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2 mm Plates and Screws) HEALIX ADVANCE BR ANCHOR SYNTHES (USA) CRANIOFACIAL PLATES SYNTHES SPINE POSTERIOR UNIVERSAL SYSTEM; K984612 PINNACLE 100 W/GRIPTION ACETABULAR CUP (SPECIAL) SYNTHES (USA) MIDFACIAL SYSTEM SYNTHES 1.5MM/2MM ORTHOGNATHIC MAXILLARY PLATES AND SCREWS GRYPHON BR AND HEALIX BR ANCHORS SYNTHES SPIRAL BLADE FOR HUMERAL NAIL (SBHN) VAPR 3 ELECTROSURGICAL SYSTEM AND VAPR LD AND LP SUCTION ELECTRODES PINNACLE CONSTRAINED ACETABULAR LINERS (TRADITIONAL) SYNTHES VECTRA SYSTEM; K050451 VAPR ELECTRODES (END EFFECT, SIDE EFFECT, WEDGE, ANGLED, HOOK, FLEX, SIDE EFFECT SHORT, AND WEDGE SHORT), VAPR TC ELECTR PROTRUSIO CAGES 4.5MM VA-LCP CURVED CONDYLAR PLATE SYSTEM ULTIMA TOTAL HIP SYSTEM CEMENTED FEMORAL STEM SUMMIT FX CEMENTED HIP STEMS 2.4 MM VA-LCP VOLAR RIM DISTAL RADIUS SYSTEM DEPUY SYNTHES VARIABLE ANGLE LOCKING HAND SYSTEM SYNAPSE SYSTEM; K133698 Expedium Spine System, VIPER and VIPER 2 Systems Revolution Radial Head VELYS Robotic-Assisted Solution SYNTHES LOCKING DISTAL RADIUS PLATING SYSTEM Corail Stem Cork HA Special 510k S-ROM TROCHANTER SCREW AND WASHER AND CALCAR REPLACEMENT FEMORAL STEM SYNTHES LCP DISTAL FEMUR PLATES SYNTHES ANTEGRA SYSTEM; K063158 SYNTHES ZERO-P; K072981 TRANSFERRED-DELTA XTEND REVERSE SHOULDER- FX INDICATION +LONG PEG METAGLENE (TRADITIONAL) APEX HOLE ELIMINATOR PS PINNACLE ACETABULAR REVISION SYS. MODIFICATION -ADD'L LG SZ'S, ADDING STANDARD PROFILE & DPX REVISION SHELLS, ADDING LIP TRAUMACEM V+ Injectable Bone Cement NORIAN DRILLABLE INJECT, NORIAN DRILLABLE FAST SET PUTTY UNIVERSAL SPINAL ROD AND SCREW FIXATION SYSTEM; K943725 SYNTHES DENTOALVEOLAR BONE FIXATION SYSTEM PIPELINE II ACCESS SYSTEM SYNTHES LIGHT GUIDE; K993314 Vertical Expandable Prosthetic Titanium Rib; K142587 Zero-P Natural Plate System; K152239 PFC SIGMA KNEE SYSTEM STABILIZED PLUS SYNTHES LCP DYNAMIC HELICAL HIP SYSTEM, ADDITIONAL HELIX BLADES SYNTHES SPINE UNIVERSAL SPINAL HOOK, ROD, PEDICLE/SACRAL SCREW FIXATION SYSTEM S-ROM FEMORAL HIP STEM (SIZES 12 X 06 X 155 & 12 X 07 X 115) SYNTHES CERVIFIX SYSTEM; K990965 Tyber Medical Trauma Screw HPS II SMOOTH STEM DePuy Synthes MAXFRAME Multi-Axial Correction System DePuy Spine_K181949 TITAN POROCOAT HIP PROSTHESIS (SUMMIT) SYNTHES CONTOURED SYNMESH SPACER; K041389 2.4MM VA-LCP DORSAL DISTAL RADIUS PLATES TRIFLANGE II ACETABULAR CUP SYSTEM (TRADITIONAL) MONARCH SPINE SYSTEM DePuy Spine_K010576 SIGMA CR-F FEMORAL COMPONENT (TRADITIONAL) (CR150... NAME MAY CHANGE AGAIN) K172157 ATTUNE REVISION KNEE SYSTEM Taps for Resorbable Screws SYNTHES WIRE MOUNT SYNTHES SPINE ANTERIOR THORACOLUMBAR ROD CLAMP (ATRC) SYSTEM; K974525 SYNTHES USS CONNECTORS; K113149 K151154 DELTA TS (TAPERED SLEEVE) CERAMIC FEMORAL HEADS (TRADITIONAL) SYNTHES (USA) LCP CURVED PLATES SYNTHES (USA) DDHS/DCS SYSTEM MODIFICATION SYNTHES (USA) STAINLESS STEEL ELASTIC INTRAMEDULLARY NAIL SYSTEM RASPS FOR SCRAPING BONE SYNTHES LCP ANKLE ARTHRODESIS PLATES ARTICUL/EZE FEMORAL HEADS Synapse Occipital-Cervical-Thoracic (OCT) System; K142838 TruMatch Graft Cage - Long Bone SYNTHES 3.5 MM AND 4.55 MM CURVED NARROW AND BROAD LOCKING COMPRESSION PLATES (LCP) Not Specified SYNTHES SPINE OCCIPITAL-CERVICAL PLATE/ROD AND HOOK SYSTEM DEPUY MITEK MILAGRO INTERENCE SCREWS SIGMA CO-CR TIBIAL TRAYS (SPECIAL 510(K))-----TIBIAL INSERTS WERE ALSO SUBMITTED BUT FDA SPLIT THEM INTO A SEPARATE 510( SYNTHES POLY (L-LACTIDE-CO-GLYCOLIDE) RESORBABLE FIXATION SYSTEM TRANSFERRED-AGILITY ANKLE REVISION PROSTHESIS Delta Xtend Reverse Shoulder Lateralized Glenosphere SYNTHES PANGEA SYSTEM; K052123 SOLUTION SYSTEM HIP PROSTHESIS (DESIGN CHANGES TO VISION K953703 & AML K012364) SPECIAL 510(K) SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEM HEALIX ADVANCE KNOTLESS PEEK ANCHOR (4.75MM)(5.5MM) SYNTHES (USA) LCP PROXIMAL FEMUR PLATE AND SCREWS SYNTHES (USA) ARTICULATING DISTAL RADIUS (ADRF) SYSTEM UNIVERSAL NAVIGATION INSTRUMENTS DEPUY ACTIS DUOFIX HIP PROSTHESIS DEPUY SYNTHES TOMOFIX OSTEOTOMY SYSTEM ATTUNE CEMENTED TIBIAL BASE, FIXED BEARING FMS VUE FLUID MANAGMENT SYSTEM, FMS CONNECT INTERFACE CABLE SYNTHES (USA) TROCHANTERIC FIXATION NAIL (TFN) SYSTEM DePuy Spine_K090230 SYNTHES (USA) MIDFACE DISTRACTOR SYNAPSE SYSTEM; K070573 SYNTHES (USA) CRANIOMAXILLOFACIAL DISTRACTION SYSTEM SYNATOMIC VARIABLE FIT TIBIAL PLATEAU TITANIUM HIP - CATALOG 1019 XX XXXSTEMS &1365 XX XXX HEADS BIO-INTRAFIX TIBIAL SCREW AND SHEATH SYNTHES 4 AND 5 MM LOCKING SCREWS Mitek VAPR System LIFELINER SURGICAL GLOVE LINER SYNTHES (USA) 3.5MM LOCKING ATTACHMENT PLATES SYNTHES ZERO-P VARIABLE ANGLE (VA); K112068 SYNTHES 3.5MM QUADRILATERAL SURFACE PLATES QUICKANCHOR, MODIFICATION S-ROM TOTAL HIP SYSTEM WITH CERAMIC HEAD MODIFICATION TO SYNTHES (USA) REAMER IRRIGATOR ASPIRATOR (RIA) SYSTEM SUMMIT OCT SPINAL SYSTEM DARWIN KNEE SYSTEM (PFC SIGMA) (CRUCIATE RETAINING) POROUS COATED AND NON-POROUS COATED (ALSO KNOWN AS PFC II KNEE SYSTE SIGMA CRUCIATE RETAINING PORO FEM COMP (TRADITIONAL) PFC TOTAL KNEE SYSTEM OVAL PATELLA SYNTHES CALCANEAL PLATE MODIFICATION TO:EXPEDIUM SPINE SYSTEM SYNTHES AIR PEN DRIVE (APD) SYSTEM SYNTHES (USA) ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEM S-ROM HIP SYSTEM -LOCKING PLUG (PIN) SYNTHES (USA) 3.5 / 4.5 MM LCP METAPHYSEAL PLATES SYNTHES DISTRACTION OSTEOGENESIS SYSTEM, MR CONDITIONAL WITH EXPANDED INDICATIONS K201145 MITEK ANCHOR II SYNTHES ELASTIC INTRAMEDULLARY NAIL (EIN) SYSTEM SYNTHES LOCKING CALCANEAL PLATES SYNTHES T-PAL SPACER; K100089 SYNTHES HIGH TIBIAL OSTEOTOMY (HTO) SYSTEM AML II (AML+) TITANIUM ACETABULAR CUP (ACS) VAPR 2.3 MM SIDE EFFECT ELECTRODE FOR USE WITH VAPR SYSTEM CLICK'X MONOAXIAL SCREWS AND HOOKS; K031175 RIGIDFIX BIOCRYL CROSS PIN KITS SYNTHES SYNEX SPACER SYSTEM; K003836 VIPER AND EXPEDIUM NAVIGATED INSTRUMENTS DePuy Spine_K200245 MODIFICATION TO SYNTHES (USA) (SYNTHES) LOW PROFILE NEURO SYSTEM FEMORAL AND TIBIAL AUGMENT BLOCKS (FOR USE WITH S-ROM NOILES MODUALR ROTATING HINGED KNEE) C-STEM SYSTEM SYNTHES ANTERIOR CSLP SYSTEM DePuy Spine_K190895 DePuy Synthes 2.4/2.7mm VA LCP Two-Column Volar Distal Radius Plate, Extra-Long PFC TOTAL HIP SYSTEM - POROUS COATED LONG STEM SYNTHES (USA) LCP PROXIMAL HUMERUS PLATES, LONG SUMMIT CEMENTED HIP PROSTHESIS PINNACLE ALTRX ACETABULAR CUP LINERS - [USE W/ CERAMIC HEADS] (TRADITIONAL) SYNAPSE SYSTEM SYNTHES OC FUSION SYSTEM; K141897 SynMesh System SYNTHES USS (10MM SIDE OPENING SCREWS); K003061 DePuy Synthes Femoral Neck System K941541 HSW Owned Laparoscope 510k SYNTHES SYNMESH; K983766 SINUSCOPE AND ACCESSORIES SYNTHES (USA) MEDIAL DISTAL TIBIA PLATES SYNTHES 3.5MM SPRING PLATE MITEK CANCELLOUS FIXATION SCREW, CORTICAL FIXATION SCREW, SOFT TISSUE WASHER TRANSFERRED-GLOBAL SHOULDER STEPTECH AUGMENTED GLENOID , (SPECIAL TO K052472) AMK 3 PEG PATELLA SYNTHES (USA) [SYNTHES] SELF-DRILLING SCHANZ SCREW SPEEDTRAP Graft Preparation System EXPEDIUM SYSTEM, VIPER SYSTEM SYNTHES (USA) TROCHANTERIC FIXATION NAIL (TFN) SCREW SYNTHES (USA) 3.5MM LCP HOOK PLATE GRYPHON Anchors with DYNACORD Suture BENGAL STACKABLE CAGE SYSTEM SYNTHS ONE-THIRD TUBULAR DCL PLATE TRANSFERRED-DEPUY NEUFLEX PIP FINGER SYNTHES CRANIOFACIAL PLATES HEALIX ADVANCE KNOTLESS BR ANCHOR USS-LINE EXTENSION; K010108 SYNTHES RADIAL HEAD PROSTHESIS SYSTEM COUGAR LS LATERAL CAGE SYSTEM SYNTHES TROCHANTERIC FIXATION NAIL (TFN) SYSTEM, ADDITIONAL HELICAL BLADES SYNTHES SYNFLATE VERTEVRAL BALLOON SYSTEM; K130146 SYNTHES (USA) ORIBITAL MESH PLATES SYNTHES MATRIXMANDIBLE PERFORMED RECONSTRUCTION PLATES ISOLA SPINAL SYSTEM SYNTHES (USA) PEDIATRIC LCP HIP PLATE SYSTEM MODIFICATIONS OMNICUT RESECTION BLADE JOHNSON & JOHNSON MODULAR TOTAL KNEE PROSTHESIS - PFC MODULAR KNEE SYSTEM (NOT SIGMA) Nails MR Conditional Synthes Reamer/Irrigator Aspirator (RIA) system SYNTHES (USA) LCP PROXIMAL FEMUR HOOK PLATES DEPUY SYNTHES INJECTABLE POLYMER SYSTEM (IPS) GRYPHON P BR DS ANCHOR W/ORTHOCORD,GRYPHON P BR ANCHOR W/ORTHOCORD, MODEL 210813,210814 CERAMIC FEMORAL HEAD (SPECIAL - DESIGN MODIFICATION TO K031803) GRYPHON T AND P BR ANCHORS 2.7/3.5MM VA-LCP ANTERIRO CLAVICLE PLATE SYSTEM SYNTHES SMALL EXTERNAL FIXATION SYSTEM, SYNTHES LARGE EXTERNAL FIXATION SYSTEM SYNTHES MINI EXTERNAL FIXATOR MODIFICATION TO: VIPER SPINE SYSTEM SYNTHES ZERO-P VARIABLE ANGLE (VA); K121852 SYNTHES (USA) LCP WRIST FUSION PLATES DEPUY C-STEM SYSTEM PANALOK WEDGE ABSORABLE SUTURE ANCHOR SYSTEM REPEL SURGICAL GLOVE LINERS PINNACLE DUOFIX HA ACETABULAR CUPS (SPECIAL 510(K) DEVICE MODIFICATION OF PINNACLE ACETABULAR CUPS) MILAGRO ADVANCE PEEK Interference Screw CONCORDE Bullet Lumbar Interbody System MODIFICATION TO: EXPEDIUM SPINE SYSTEM 4/2.5 MM SELF-DRILLING SCHANZ SCREW VAPR COOLPULSE CURVE Suction Electrodes EXPEDIUM VERSE SPINE SYSTEM SYNTHES MATRIXMANDIBLE PLATE AND SCREW SYSTEM SYNTHES LARGE COMBINATION CLAMP AND DYNAMIZATION CLIP - MR SAFE VAPR ARCTIC SUCTION ELECTRODE SYNTHES LOW PROFILE RECONSTRUCTION PLATES TRUMATCH PATIENT SPECIFIC INSTRUMENTS RIGIDLOOP Cortical Fixation System XL Implant SYNTHES (USA) LARGE EXTERNAL FIXATION CLAMPS-MR SAFE SYNTHES (USA) 6.5 MM CANCELLOUS SCREWS SYNTHES 2.7MM AND 3.5MM VARIABLE ANGLE LCP MIDFOOT/HINDFOOT SYSTEM MINI QUICKANCHOR AND QUICKANCHOR PLUS WITH ORTHOCORD SYNTHES (USA) ELASTIC INTRAMEDULLARY NAIL (EIN) END CAP ANTEGRA-T; K081568 M-SPEC 36MM FEMORAL HEADS (TRADITIONAL) {EXTENSION TO K980513 & K003523} SYNTHES CORTICAL SCREWS MATRIXRIB FIXATION SYSTEM TRANSFERRED-GLOBAL UNITE SHOULDER SYSTEM SYNTHES STRAIGHT WRIST FUSION PLATE, 170MM MERLIN SPINE SYSTEM PINNACLE W/ GRIPTION ACETABULAR CUPS (SPECIAL) SYNTHES SYNMESH SPACER SYSTEM; K003275 SYNTHES CANNULATED ANGLE BLADE PLATE (CABP) SYSTEM SYNTHES (USA) 2.4MM LCP VOLAR COLUMN DISTAL RADIUS PLATES HEALIX ADVANCE PEEK ANCHOR DePuy Spine_K122861 XTOOL AML HIP PROSTHESIS Synthes (U.S.A) Resorbable Fixation System Dental Bone Cutting Instruments VERSALOK ANCHOR WITH FREE STRANDS OF ORTHOCORD SUTURE (210808), ETHIBOND SUTURE (210809), AND PANACRYL SUTURE (210810) SYNTHES 2 MM LOCKING PLATE SYSTEM (2 LPS) GRYPHON PEEK DS ANCHOR W/ ORTHOCORD, GRYPHON PEEK ANCHOR W/ ORTHOCORD Corail Line Extension MINILOK QUICKANCHOR PLUS SYNTHES MIDFACE DISTRACTOR MARATHON CROSS-LINKED POLY ACET. CUP LINERS (FORMERLY CALLED DURALOC) SYNTHES (USA) PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANTS SYNTHES STAINLESS STEEL MODULAR HAND SYSTEM S-ROM ZTT SLEEVES MILAGRO INTERFERENCE SCREWS DURALOC CEMENTLESS ACETABULAR CUP SYSTEM SIGMA TIBIAL INSERTS [BANNISTER - GVF] (SPECIAL OFF DARWIN K943462)082627 SYNTHES (U.S.A.) ANTERIOR CERVICAL VERTEBRAE PLATE SYNTHES (USA) 1/1.22 MM CRANIOFACIAL SCREWS PROXIMAL FEMORAL NAIL (PFN) SYSTEM PINNACLE W/ GRIPTION ACETABULAR CUPS (SPECIAL) -ADDING DEVICE CODES KWA, JDI, LZO MODIFICATION TO SYNTHES UNIVERSAL SPINAL SYSTEM; K990745 SYNTHES MATRIX SYSTEM; K092929 SYNTHES TROCHANTERIC FIXATION NAIL - ADVANCED SYSTEM TROCHANTERIC REATTACHMENT DEVICE (STANDARD) AND (LONG), MODEL 501-066, 501-067 DEPUY SPINE LATERAL CAGE SYSTEM CLAMPFIX; K090605 MODIFICATION TO MOSS MIAMI SPINAL SYSTEM POLYAXIAL SCREWS SYNTHES ANTERIOR CERVICAL LOCKING PLATE (ACLP) SYSTEM; K031276 TRANSFERRED-GLOBAL CAP HA RESURFACING SHOULDER HUMERAL HEADS (SPECIAL) DESIGN CHANGE TO K031971 LCP RADIAL HEAD PLATING SYSTEM SYNTHES (USA) STERNAL FIXATION SYSTEM - LINE EXTENSION SYNTHES (USA) 2.7MM/ 3.5MM LCP ANTEROLATERAL DISTAL TIBIA PLATES SYNTHES 3.5 MM LCP DISTAL TIBIA T PLATES SYNTHES 3.5 MM VA-LCP PROXIMAL TIBIA PLATE SYSTEM Additional VIPER PRIME screws with fenestrations AML HIP - RAW MATERIAL CHANGE FROM CAST TO FORGED (FROM ORIG. K012364) K151004 MODULAR CATHCART FRACTURE SYSTEM SMALL TITANIUM WRIST FUSION PLATE SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM 2.4MM CORTEX SCREW, SELF-TAPPING USS VAS; K002517 SYNTHES(USA) SYNTHES HYBRID EXTERNAL FIXATOR Trauma Devices - MR Conditional SYNTHES (USA) NEW/STERIAL ORBITAL PLATES MODIFICATION TO SYNTHES USS; K000450 VAPR VUE RADIOFREQUENCY SYSTEM ,MODEL 225024, VPR VUE WIRELESS FOOTSWITCH, MODEL 227214 SYNTHES VA LCP ANKLE TRAUMA SYSTEM DEPUY/DUPONT REPEL GLOVES (SZ LARGE/MEDIUM) Speed, Speed Shift, Speed Titan, Speed Arc K123359 Purevue Camera Control System SYNTHES 2.4 MM/2.7 MM VARIABLE ANGLE LCP FOREFOOT/MIDFOOT SYSTEM SYNTHES POSTERIOR UNIVERSAL SPINAL SYSTEM SYNTHES TI-6AI-7NB UNREAMED FEMORAL NAIL FMS DUO SYSTEM SIGMA HIGH PERFORMANCE PARTIAL KNEE SYSTEM [PREVIOUSLY CALLED - GCK FEMORAL AND TIBIAL COMPONENTS] (TRADITIONAL) DYNATAPE Suture DePuy Synthes 2 mm Quick Insertion Screws SYNTHES 1.5MM TI BROW LIFT SCREW SYNTHES (USA) EXTERNAL MULTI VECTOR MANDIBLE DISTRACTOR DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm) SYNTHES REUSABLE STERILIZATION CONTAINER SYSTEM Special 510k for 6.5mm HEALIX ADVANCE SP PEEK & Biocomposite Anchors SPL CRIMP SYSTEM; K002110 SYNTHES BUTTON PLATE VBB SYSTEM; K110604 SIGMA PS (POSTERIOR-STABILIZED, CRUCIATE SUBSTITUTING) FEMORAL COMPONENTS -DEVICE MODIFICATION (SPECIAL) PFC SIGMA KNEE SYSTEM (SIZE 1.5) SYNTHES THORACOLUMBAR SPINE LOCKING PLATE (TSLP); K020244 AMK FEMORAL, TIBIAL TRAYS, INSERTS, PIN AND CLIP, PATELLA RECLAIM REVISION HIP SYSTEM (TRADITIONAL) FOR METAL ON METAL, METAL ON POLY, AND CERAMIC ON POLY ARTICULATION CEMENT EXTRACTOR DRILL SYNTHES CRANIAL FLAP TUBE CLAMP SYNTHES (USA) DISTAL RADIUS PLATE SYSTEM (DRPS) SYNTHES (USA) 2.4MM VA-LCP TWO-COLUMN NARROW VOLAR DISTAL RADIUS INTRAFIX(TM) Advance Tibial Fastener System NOILES TOTAL KNEE PROSTHESIS ORTHOGENESIS LPS PROXIMAL TIBIAL REPLACEMENT SYSTEM TRANSFERRED-GLOBAL ADVANTAGE HUMERAL STEM W/POROCOAT SYNTHES (USA) DHS HELIX SYSTEM SYNTHES (USA) 3.5/4.5MM LCP MEDIAL PROXIMAL TIBIA PLATES THE BRIGHT MEDICAL DILATION RETRACTOR SYSTEM DePuy Spine_K173095 SYNTHES TOMOFIX(TM) MEIAL HIGH TIBIA PLATE, SMALL SYNTHES MAXILLOFACIAL TITANIUM MICRO SET MICROFIX QUICKANCHOR PLUS SUMMIT SI OCT Spinal Fixation System, MOUNTAINEER OCT Spinal System SYNTHES (USA) HYDROXYAPATITE (HA) COATED SCHANZ SCREWS TRUMATCH Patient Specific Alignment (PSA) PINNACLE ALTRX ACETABULAR LINERS - TRADITIONAL THE SYNTHES MATRIXMANDIBLE PLATE AND SCREW SYSTEM SYNTHES MATRIX SYSTEM; K120838 ATTUNE All Polyethylene Tibia BENGAL SYSTEM, BENGAL STACKABLE SYSTEM, CONCORDE BULLET LUMBAR, CONCORDE INLINE LUMBAR, COUGAR SYSTEM, COUGAR LS LATERAL TRANSFERRED-DELTA XTEND REVERSE SHOULDER POLY CUP XLK [CROSSLINK] (SPECIAL) 2.4MM VA-LCP INTERCARPAL FUSION SYSTEM SYNTHES 2.4 MM TITANIUM (TI.) LOCKING SCREWS (TRANSFERRED) STEAM STERILIZATION UPDATE (REMOVED MR COMPATIBILITY] FOR MULTIPLE TRAUMA INTERNAL FIXATION SYSTEMS (BUNDL SYNTHES POSTERIOR UNIVERSAL SPINAL SYSTEM; K983530 HEALIX ADVANCE KNOTLESS BR ANCHOR (6.5MM) SYNTHES (USA) 3.5MM LCP POSTEROMEDIAL PROXIMAL TIBIA PLATES DURALOC ACETABULAR CUP SYSTEM 36MM MARATHON +4 POLYETHYLENE LINERS VERTECEM II CEMENT KIT UNIVERSAL KNEE STEM EXTENSIONS / FEMORAL METAPHYSEAL SLEEVES (PFC, SIGMA, S-ROM, LPS, LPS) [TRADITIONAL ] SYNTHES ACIS/VERTEBRAL SPACER CR; K120275 SIGMA XLK TIBIAL INSERTS [BANNISTER] (TRADITIONAL) SYNTHES ORACLE SPACER; K062933 SYNTHES (USA) PEDIATRIC LCP HIP PLATE SYSTEM SYNTHES (USA) TROCHANTER STABILIZATION PLATE FOR DHS SYNTHES (USA) 2MM TITANIUM T-PLATE ZTT I AND II ACETABULAR CUP OF THE S-ROM TOTAL HIP PFC MODULAR KNEE SYSTEM SET SCREW FOR TI TROCHANTERIC FIXATION NAIL(TFN) DEPUY ECLIPSE HIP PROSTHESIS (ACTIS) SYNTHES 3.5MM CORTEX SCREWS SYNTHES (U.S.A.)UNIVERSAL SPINAL PARELLEL CONNECTOR THE UNIVERSAL SPINAL ROD AND SCREW FIXATION SYSTEM; K964416 SYNTHES (USA) NEURO PLATE AND SCREW SYSTEM SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS

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