FDA Registration Active 🇳🇱 Netherlands

Biomet Global Supply Chain Center B.V.

Reg #: 3013055499 · FEI: 3013055499 · Expires 2026
Products
102
Proprietary Names
165
Establishment Types
1
Classifications
102

Registration Details

Registration Name
Biomet Global Supply Chain Center B.V.
Registration Number
3013055499
FEI Number
3013055499
Status
Active
Expiry Year
2026
Initial Importer
No
Address
4836 LD Breda
City
Hazeldonk Noord-Brabant
Country
NL

Regulatory Submissions

510(k) Number
K093549
PMA Number
P110009

Owner / Operator

Firm Name
ZIMMER GMBH
Operator Number
9064978
Address
Zahlerweg 4
City
Zug
State
CH-ZG
Postal Code
6300
Country
CH

US Agent

Business Name
Zimmer Biomet
Contact Name
Stephanie Lynch
Address
1800 W Center St
City
Warsaw
State
IN
ZIP
46580
Country
US
Phone
715 9289253

Products

Device Name Product Code
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented LWJ
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish MAY
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI
Plate, Fixation, Bone HRS
Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented OQH
Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented OQI
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer KWZ
Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented OQG
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive PBI
Rod, Fixation, Intramedullary And Accessories HSB
Orthosis, Spinal Pedicle Fixation MNI
Appliance, Fixation, Spinal Interlaminal KWP
Orthosis, Spondylolisthesis Spinal Fixation MNH
Forceps HTD
Tube, Tracheal (W/Wo Connector) BTR
Motor, Surgical Instrument, Ac-Powered GEY
Curette HTF
Instrument, Cutting, Orthopedic HTZ
Screw, Fixation, Bone HWC
Spinal Vertebral Body Replacement Device MQP
Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer KRR
Countersink HWW
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
Thoracolumbosacral Pedicle Screw System NKB
System, Facet Screw Spinal Device MRW
Battery, Replacement, Rechargeable MOQ
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented KWY
Intervertebral Fusion Device With Bone Graft, Cervical ODP
Chisel, Surgical, Manual FZO
Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) KWA
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate MEH
Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) JDL
Prosthesis, Hip, Hemi-, Femoral, Metal KWL
Bone Fixation Cerclage, Sublaminar OWI
Surgical Table Cushion LWG
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive OIY
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer MBH
Template HWT
Prosthesis, Intervertebral Disc MJO
Bone Mill LYS
Rasp HTR
Instrument, Bending Or Contouring HXP
Bender HXW
Pin, Fixation, Smooth HTY
Spinous Process Plate PEK
Component, Traction, Invasive JEC
Tape, Orthopedic HXT
Staple, Fixation, Bone JDR
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component KTT
Guide, Surgical, Instrument FZX
Driver, Prosthesis HWR
Burr, Orthopedic HTT
Pin, Fixation, Threaded JDW
Intervertebral Fusion Device With Integrated Fixation, Lumbar OVD
Intervertebral Fusion Device With Bone Graft, Lumbar MAX
Intervertebral Fusion Device With Integrated Fixation, Cervical OVE
Gouge, Surgical, General & Plastic Surgery GDH
Bone Grafting Material, Synthetic LYC
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer HRY
Pusher, Socket HXO
Screwdriver HXX
Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing NRA
Saw, Powered, And Accessories HAB
Device, Fixation, Proximal Femoral, Implant JDO
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite LXT
Washer, Bolt Nut HTN
Gauge, Depth HTJ
Appliance, Fixation, Spinal Intervertebral Body KWQ
Tape, Measuring, Rulers And Calipers FTY
Caliper KTZ
Elevator HTE
Awl HWJ
Cerclage, Fixation JDQ
Hammer, Surgical FZY
Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained PKC
Impactor HWA
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWS
Scissors, Orthopedic, Surgical HRR
Bone Cement, Antibiotic MBB
Bone Cement LOD
Punch, Surgical LRY
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing NJL
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer MBV
Hook, Surgical, General & Plastic Surgery GDG
Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented HSD
Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented KWT
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented PAO
Shoulder Prosthesis, Reverse Configuration PHX
Orthopedic Manual Surgical Instrument LXH
Tray, Surgical, Instrument FSM
Wrench HXC
Reamer HTO
Extractor HWB
Tap, Bone HWX
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented MBF
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer KRO
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer HSX
Retractor GAD
Bit, Drill HTW

Proprietary Names

44MM E1 ACETABULAR LINER WITH 44MM BIOLOX DELTA OPTION CERAMIC HEAD OR 44MM M A MAGNUM ACE BROOKER BONE PLATING SYSTEM G7 OSSEOTI ACETUBLAR SHELLS DEPUY ACE A.I.M. TITANIUM TIBIAL NAIL Wagner SL and Wagner Cone Stems DEPUY ACE TIMAX META PLATE LDR SPINE USA SPINE TUNE TL SPINE SYSTEM Biolox® delta Ceramic Heads, Biolox® delta Option Ceramic Heads MR Labeling Zimmer GmbH STAPLE, FIXATION BONE; SCREW FIXATION BONE ARCOM POLYETHYLENE ACETABULAR LINERS & COMPONENTS ZIMMER BIOMET Normed Sulzer Ortho MS-30 Femoral Stem SMALL BONE LOCKING PLATING SYSTEM SCARF THREAD-HEAD SCREW MODIFICATION OF DEPUY ACE TIMAX MEDIAL PILON PLATE DEPUY ACE UNIVERSAL AND TROCH ENTRY FEMORAL NAIL SYSTEMS LDR SPINE ROI-C IMPLANT UNICOMPARTMENTAL PATELLOFEMORAL PROSTHESIS (UPP) CEMENTED NEXGEN COMPL. KNEE SOL. LEGACY POSTERIOR STABILIZED/CONSTRAINED CONDYLAR KNEE FEMORAL COMPONENTS/ARTICULAR SURFACES NEXGEN KNEE GENDER SOLUTIONS FEMALE (GSF) FEMORAL COMPONENTS INSTINCT JAVA SYSTEM Biolox delta Ceramic Heads, Biolox delta Option Ceramic Heads FacetBRIDGE System THACKRAY TITANIUM MINI-PLATING SYSTEM EASYSPINE SYSTEM Zimmer, Inc. Hip Joint Prostheses MR Labeling I LDR SPINE CERVICAL INTERBODY FUSION SYSTEM Wagner Revision Femoral Hip Prosthe G7 Dual Mobility System OPEN RADIOTRANSPARENT INTERSOMATIC IMPLANT (ROI) NCB Polyaxial Locking Plate System LOCKING ANATOMIC & COMPOSITE PLATING SYSTEM TAPERLOC COMPLETE, SIZE 5 AND 6 Universal Clamp Spinal System ZIMMER PERSONA THE PERSONALIZED KNEE SYSTEM TMARS Provisional Template Fitmore Z Porolock MIS Stem LDR SPINE SPINETUNE TL SPINAL SYSTEM G7 ACETABULAR SYSTEM Wagner SL Revision Stem Lateral TWIST-OFF (TM) SCREW NCB Plating System Distal Femur and Proximal Tibia Biolox Delta Ceramic Femoral Heads, Biolox Option Ceramic Femoral Head System AGC TOTAL KNEE SYSTEM KNEE, ASCENT TOTAL KNEE SYSTEM, MAXIM COMPLETE KNEE SYSTEM, MAXIM ACCEL KNEE SYSTEM ALSO KNOWN Mobi-C Cervical Disc Prosthesis ZINDRICK IM ROD INSTRUMENTS TAPERLOC COMPLETE Biomet Proximal Humerus Plating System ACE CANCELLOUS BONE SCREW NANCY NAIL ACE HUMERAL NAIL NTERBRIDGE INTERSPINOUS POSTERIOR FIXATION SYSTEM ACE OPEN-BACK HALO RING G7 Finned Acetabular Shell Alloclassic Zweymuller SL Femoral Stem, Alloclassic Zweymuller SL Offset Femoral Stem MEMORY STAPLE ACE/KYLE CAPTURED HIP SCREW ACE MULTIPLE PIN PLATE 6.5MM SOLID CANCELLOUS BONE SCREW Orthopedic manual surgical instrument. 4.5MM LOCKING BROAD & NARROW COMPRESSION PLATES, 4.5MM & 5.5MM CORTICAL & CANCELLOUS LOCKING SCREWS, RESPECTIVELY BIOLOX DELTA CERAMIC HEADS ZIMMER PERSONA TM PERSONALIZED KNEE SYSTEM LDR SPINE ROI-A IMPLANT Zimmer Gmbh BIOLOX(R) DELTA CERAMIC HEADS G7 Freedom and Offset Liners, Freedom Head, Size 32 DEPUY ACE VERSANAIL TIBIAL NAIL ZIMMER PERSONA KNEE SYSTEM PE.R.I. II KNEE FRACTURE SYSTEM VerteFIT Corpectomy Cage System Trabecular Metal Acetabular Revision Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T Implant System ROI-C Titanium-Coated Implant System TAPERLOC COMPLETE MICROPLASTY STEM ENDOBON XENOGRAFT GRANULES OXFORD UNICOMPARTMENTAL KNEE FEMORAL COMPONENT ACE AIM TTC FUSION NAIL EBI X FIX DYNAFIX SYSTEM (DFS) Oxford Partial Knee System Avenue® T TLIF Cage Zimmer Persona Personalized Knee System CLOSED FUSION PLATE, MTP PLATE, TALUS PLATE, MODEL 824077021, 22; 824677021, 22, 824071001, 824071101, 824671001, 82467 ACE BIO WIN TIBIAL NAILING SYSTEM LDR SPINE ROI-A INTERBODY FUSION SYSTEM LDR SPINE EASYSPINE POSTERIOR OSTEOSYNTHESIS SYSTEM DEPUY ACE AIM TITANIUM TIBIAL NAIL UNIVERSAL AND TROCH ENTRY FEMORAL NAILING SYSTEMS LINE EXTENSION LDR SPINE USA AVENUE L INTERBODY FUSION MCK MAXIMUM CONGRUENT KNEE) KNEE SYSTEM REVERSE CUTTING CANNULATED CANCELLOUS BONE SCREW POLYAX LOCKED PLATING SYSTEM AIM SUPRACONDYLAR NAIL HIPLOC COMPRESSION HIP SCREW Avenir Complete Hip System, Size I Coxa Vera Zimmer Biomet Ceramic Heads TRAUMA INTERNAL FIXATION SYSTEMS NEXGEN COMPLETE KNEE SOLUTION CRUCIATE RETAINING (CR)-FLEX FEMORAL COMPONENTS LDR SPINE USA C-PLATE, TL ANTERIOR CERVICAL PLATE SYSTEM Affixus® Natural Nail® System Humeral Nail Zimmer GmbH Hip Joint Replacement-MR Labeling ACE CANNULATED SELF TAPPING CANCELLOUS BONE SCREW ACE VERSANAIL LDR SPINE CERVICAL INTERBODY FUSION SYSTME-ROI-C LORDOTIC IMPLANTS Avenir Complete Hip System INTER-OP DURASUL ACETABULAR INSERTS/COCR FEMORAL HEADS Fitmore Hip Stem LDR SPINE USA SPINETUNE TL SPINAL SYSTEM ABBOTT SPINE UNIVERSAL CLAMP SYSTEM LDR SPINE EASYSPINE SYSTEM TROCHANTERIC NAIL SYSTEM HFN 125 DEGREE 9-13 MM, 180MM, HFN 130 DEGREE 9-13 MM, HFN RH 125 DEGREE 9-13MM EBI XFIX DYNAFIX SYSTEM HA COATED SCREWS ACE RECONSTRUCTIVE PLATE MODIFICATION TO LDR SPINE ROI INTERBODY FUSION SYSTEM; ROI-A IMPLANT SYSTEM DEPUY AE TK2 HIP SCREW SYSTEM A. L. P. S. Clavicle Plating System Sidus Stem-Free Shoulder TWIST-OFF SCREW DEPUY ACE AIM(R) TITANIUM SUPRACONDYLAR NAIL ARCOMXL Polyethylene Liners and BIOLOX Delta Heads ARCOS INTERLOCKING DISTAL STEMS Anatomical Shoulder Keeled Glenoid FRS SCREW ANTEROLATERAL AND MEDIAL LOCKING PLATING SYSTEM Refobacin Bone Cement R MODIFICATION TO: LIGAFIX INTERFERENCE SCREW ACE 3.5MM CORTICAL BONE SCREW ACE HUMERUS & RADIUS PLATES ZINDRICK IM ROD BIOLOX DELTA CERAMIC OPTION HEADS Zimmer Natural Nail System Cephalomedullary Nails TAPERLOC COMPLETE SIZE 4MM AND XR 123 Zimmer Biomet 12/14 CoCr Femoral Head and Freedom Head MEMORY STAPLE (20 SIZES AVAILABLE) NEXGEN LPS-FLEX MOBILE BEARING KNEE VANGUARD 360 REVISION KNEE SYSTEM ANATOMIC LOCKING PLATING SYSTEM FacetBRIDGE® System APPLICATOR TIP/DUAL SPRAYER KIT ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined System Zimmer Biomet Select Ceramic Heads ACE CORTICAL BONE SCREW LDR SPINE ROI INTERBODY FUSION SYSTEM LIGAFIX INTERFACE SCREW BIOLOX DELTA OPTION CERAMIC HEADS Biomet Bone Cement R ARCPM 1050 RESIN-HIPS Anatomical Shoulder System NEXT GENERATION KNEE SYSTEM ACE NANCY NAIL COMPREHENSIVE PRIMARY SHOULDER STEMS Affixus Humeral Stem ACE ANTEGRADE RETROGRADE HUMERAL NAIL SYSTEM Zimmer Knee Joint Replacement Prostheses MR Labeling MULTIPLICITY OF PRODUCTS AGC TOTAL KNEE PROSTHESIS Avenir Muller Stem, Avenir Cemented Hip Stem Persona Partial Knee System LDR SPINE USA SPINE TUNE, TL SPINAL SYSTEM, LDR SPINE USA EASYSPINE, POSTERIOR SPINAL SYSTEM, LDR SPINE USA MC IMPLANT S NEXGEN COMPLETE KNEE SOLUTION LEGACY POSTERIOR STABILIZED (LPS); LPS-FLEX FIXED BEARING FEMORAL AND ARTICULAR SURFACE CO SMALL FRAGMENT LOCKING PLATING SYSTEM

Establishment Types

Export Device to the United States But Perform No Other Operation on Device