FDA Registration Active 🇺🇸 United States

Affiniti Humeral Instrument kit

Reg #: 3005061536 · FEI: 3005061536 · Expires 2025
Products
1
Proprietary Names
378
Establishment Types
2
Classifications
1

Registration Details

Registration Name
SYMMETRY MEDICAL MANUFACTURING INC
Registration Number
3005061536
FEI Number
3005061536
Status
Active
Expiry Year
2025
Initial Importer
No
Address
111 N. CLAY
City
CLAYPOOL
State
IN
ZIP
46510
Country
US

Owner / Operator

Firm Name
Tecomet
Operator Number
1828464
Address
170 New Boston Street, --
City
Woburn
State
MA
Postal Code
01801
Country
US

Products

Device Name Product Code
Orthopedic Manual Surgical Instrument LXH

Proprietary Names

Affiniti Humeral Instrument kit MTO 7x11 tray Manual General Manual Hip Patella Preparation Duracon Summit Std Imp-Inserter Manual Knee ADJ ALIGN BLOCK TIB RMRS, ROTATING PLATFO VOLAR CASE LID Probe DJO Surgical Caliper Encompass Hip System Orthopedic manual surgical instrument DJO Surgical Broach Handle Reference Frame Spacer ZIMMER TO HUDSON ADAPTER STEM IMPACTOR NATURAL IMPLANT ROD THREA ART SURF REMOVAL INST ART SURF INSERT INST T30 CANNULATED DRIVER, WITH 1/4" SQ CONECTOR TRAY ASSY, STAYFUSE MTO 7x11 SNG DP Tray (98-17110) AFP QUICK LAUNCH CASE ASSEMBLY Top Ratchet Reference Frame Right Bone Tap, Cortical First Step DJO Surgical Acetabular Retractor TIBIAL DEPTH RESECTION STYLUS SPOUT MILL CUTTER MOD TAPER SEATING CONNECTOR DJO Surgical Cut Block STAYFUSE SEPARATOR INSTRUMENT Affiniti Humeral Top Tray Affiniti EH2 Instrument Lid BOM IFPP Base IM TIBIAL RESECTOR 7 DEGREE Reunion Wave Plate Caddy Insert Wave Case Lid BOX,FULL OVERLAP, WHITE, 103/4X31/2X215/8 PAT INSR ASSY MOST LID FOR STAYFUSE CASE Wave Case Base Insert Top Stabilizer Gage Accolade Bone Hook TIBIAL BROACH IMPACTOR LATITUDE EV INSTRUMENT CASE 1 Worland Tibial Impaction PreCept & Armada Discectomy Instruments DJO Surgical Bone Hook General Hip Instrumentation AXIAL ALIGNMENT ROD ASS'Y DJO Surgical Pelvis Elevator Wave Lag Screw Index Caddy VOLAR CASE SCREW CADDY NEXFIX NCP SYSTEM, MEASURING GUIDE FEM GDE BUSHING APR 19MM TROCHANTER BURR N-K II PARALLEL PATELLA C TRAXIS INSTRUMENTS AFFINITI EH2 INSTRUMENT TRAY Wave Non Locking Fully Threaded Screw Index Caddy Scorpio AFFINITI EH2 52MM TUBEROSITY REAMER General Knee Instrumentation STM EXT THUMBSCREW Hip Revision LID FOR VOLAR CASE Aequalis Humeral Nail Case Screw Caddie Ascend Modular Anatomic Instrument Case FORTITUDE INSTRUMENTS Extended Tibial Entry Sheath Handle Cutting Edge Lobster Claw HD HLDR Offset Shell Inserter A/P SIZER, TOWER Hex Driver Dall Miles Orthopedic manual instrument CFP QUICK LAUNCH 2 LOCKING SCREW CADDY Affiniti EH2 Instrument Tray BOM SPIKE ARM TELESCOPING ROD MIS DISTAL TELESCOPING ROD FOOT HOLDING FIXTURE Aequalis Humeral Nail Case Outer 1 Wave Lag Screw Caddy Cannulated Hex Driver Pedicle Finder DJO Surgical Retractor Rejuvenate DJO Surgical Drill Guide Handle T-HANDLE ZIMMER ATTACHMENT FEM NOTCH CUT BLOCK NK CO Distal Guide CALCANEAL FRACTURE PLATE QUICK LAUNCH CASE Affiniti Humeral Base BIOMET ORTHOPEDIC MANUAL SURGICAL INSTRUMENT General Hip AFFINITI EH2 44MM TUBEROSITY REAMER FEM LOCKING PIN INSR/EXT Partnership Wave Plate Caddy Aequalis Humeral Nail Case Upper Tray Introducer FEM SIZE GUIDE 60 NK PAT OSTY GD ASSY Wave Calcaneal Fracture Plating System Sterilization Aequalis Humeral Nail Case Lid1 Affiniti Humeral Middle Tray VOLAR CASE OUTER DJO Surgical Femoral Head Corkscrew Champion Shoulder Instrumentation Solid Hex Driver Meniscal Transplantation Slot Instruments General Trauma Instrumentation PROV FEM STEM PROX FEM RULER MOST SLOTTED NOTCH GDE SZ AB Bone Holding Forceps, Verbrugge DVO Volar Plate Case - Lid EU ArthroCare, Tray, Box, and Bag Ascend Modular Reverse Instrument Case PCA Knee Instruments/Other HTO OST GUIDE ASSY LATITUDE QLS REVISION CASE AFFINITI EH2 INSTRUMENT BASE GMRS DJO Surgical RSP Monoblock Impaction Fixture CONSENSUS ORTHOPEDICS, INC. T-Handle, Zimmer, Assy SPIKE ARM TIBIAL TUBURCLE ALIGNMENT BAR MTO 7x11 SNG SH Tray (07-0395) ITST Fixation SCP Guide Wire Sleeve 1.4mm MRH DJO Surgical RSP Trial Adaptor DISTAL TELESCOPING ROD CUT GUIDE TELESCOPING ROD CFP QUICK LAUNCH SCREW CADDY (LOCKING SCREWS) LATITUDE QLS PRIMARY CASE - HUMERAL Calibrated Introducer 11-18007-000-00 11-18146-000-00 Direct Anterior Instruments S-ROM Universal Impactor Stem ESCALATE AWL Verte-stack Spinal System N-K II Proximal Tibia Ali 11-18008-000-00 C-Taper Head Revision Cutting Block ESCALATE COLLAPSER BLOCK SecufFit Tri-plus Acetabular Shell Direct Anterior Instrument Pagoda Pedicle Screw System Encompass Plasma Spared, Press-fit Hip System ESCALATE EXPANDER ESCALATE SCREWDRIVER INTESS CERVICAL ESCALATE PLATE HOLDER 11-18142-900-00 ESCALATE LAMINA ELEVATOR DJO Surgical Elevator V40 Femoral Head COSMOLOCK Triathlon Trial Component Biomet Screwdriver Drill Bit, 8MM Fortitude Tapered Tial DJO Surgical Rasp Hudson Broach Blank Tri-plus DCM Liner AGC Tibial Resection QUANTUM SPINAL FIXATION SYSTEM CONTACT ALP ANTERIOR LUMBAR PLATE SYSTEM, C-PLUS PEED VBR/IBF SYSTEM INSTRUMENT Locking Screw Retaining Rod DJO Surgical Head Gage Plate Meta-Tan TOTAL JOINT ORTHOPEDICS, INC. Profemur AM Rasp Mcelroy BHR MIS QUAD-SPARING TOTAL KNEE PROCEDURE CORAIL2 STRAIGHT BROACH HANDLE MBT TRAY TRIAL LITE PLATE SYSTEM Herbert/Whipple Bone Screw System Integra Surgical Instrument BIOMET END CAP REMOVAL TOOL Klassic Balanced Knee System FEMORAL IMPACTOR REPLACEMENT NYLON ITST Intertrochangeric/Subtrochanteric Fixation Corail AMT Modular Bone Impactor PIN PULLER Biomet Orthopedic LCS PW IM PLATE 0 DEG POLY EXTRACTOR RECLAIM DISASMBLY THREADED CAP 4TH DILATOR SPOTLIGHT TC3 BOX TRIAL MBT KEEL PUNCH IMPACT DEPUY RECLAIM DISASSEMBLY HANDLE MODULAR STEM ADAPTER POWER PIN DRIVER Periarticular Plate Distal Lateral Femoral Plate Jig Right PROXIMA CANAL FINDER FEM REV A/P CUTTING GDE BUSHING STEINMAN PIN INSERTER Temporary Fixation Pin ALTERNATE BEARING FEMORAL HEAD TRIAL TRAY TRIAL ALIGNMENT HANDLE TIBIAL TRAY TRIAL CRUCIATE SUBSTITUTING BOX TRIAL ARTIC/EZE TR BALL GRVD OFFSET TIB NCEM PNCH GDE SZ 1.53 General Instrumentation 1.6mm Adjustable Parallel Wire Guide RP TIBIAL TRAY IMPACTOR MBT KEEL PUNCH CEMENTED MBT KEEL PUNCH NONCEMENTED DEPUY RECLAIM DISASSEMBLY TOOL ASSEMBLY Neuflex MCP Broach SZ 10 Prox 1.25mm Cleaning Stylet CEMENTED MODULAR PUNCH GUIDE STANDARD PUNCH GUIDE Tibial Insert Trial Remover ALIGNMENT TOWER POLYETHYLENE TIBIAL CONDYLE IMPACTOR AML BROACH HANDLE ENDURANCE BROACH HANDLE Corail AMT Trochometer SP2 MI FEM NOTCH GD DEPUY RECLAIM DISTAL REAMER EXTENSION 4.5/3.2mm Double Drill Sleeve FEM REV A/P CUTTING GDE BUSHING-OFFSET MBT SPACER BLOCK NON-CEMENTED MODULAR PUNCH GUIDE FBT SPACER BLOCK Pointed Forceps w/ Rachet, Narrow Long ENCORE REVERSE HUMERAL PLANAR, SMALL Ring Curette TIBIAL TRAY HANDLE DEPUY RECLAIM DISASSEMBLY TORQUE HANDLE ARH Slide-Loc Stem Clamp Pointed Forceps w/ Ratchet, Wide Long 2.7/1.3mm Double Drill Sleeve 3.5mm Cannulated Hex Driver, QC Acetabular Retractor, Deep, Right 3/3.5/4mm Holding Sleeve Attune DAA BENT HOHMAN RETRACTORS,<br>LEFT Octane Cup Curette MBT Broach Corail AMT 13 Tibial Sizing Template Handle Assembly MBT Punch Bullet (Non-Ribbed) Sizes 1 thru 7 Cement Restrictor Trial 1.35mm Cleaning Brush Fragment Plate Cutter Pinnacle Cup System Acetabular Retractor, Deep, Left Sigma DAA BENT HOHMAN RETRACTORS,<br>RIGHT Octane LCS PW IM Plate 6 Deg LT 3/3.5mm Screw Sizer Reduction Forceps w/ Rachet, Long T15 Stick Fit Toggling Hexalobe Driver Duraloc Cup System Hohmann Retractor, Deep, Left Optetrak Obsolete - SROM Oblong Cup FEMORAL NECK ELEVATOR 3.5mm Solid Hex Driver, QC LCS T-Handle Reamer CSR Shoulder System Compress Instruments MRI Crochet Hook Mueller Cement Removal Instrument Case Custom Quick Launch Tray Manual Revision General Screw Removal C-Assist SuperCable Iso-Elastic Cerclage (Tray Only) Omnifit Cannulated Drill Bit TROCHANTER BURR 13MM APR LATITUDE QLS PRIMARY CASE - ULNAR DJO Surgical RSP Impaction Fixture Bottom Ratchet RMR HOUSINGS, ROTATING PL TAPER SEATING TOOL Bottom Stabilizer Aluminum Tray with Brackets Anchor Depth Gauge DJO Surgical Depth Gage I-Hip Handle STM EXT ASSY GLENOID PLANER REAMER SHAFT TIBIAL BOOM 7 DEGREE Direct Anterior Triathlon FEM HINGE ALGNR MOST HEAD INSERTER STEM ALIGNMENT GUIDE Cushing Elevator, Fan Tip IFPP Screw Caddy Hand Held Fracture Jig Case Affiniti EH2 Instrument Base BOM AEQUALIS REV. II REAMER CASE ASSEMBLY VOLAR PEG-LAG SCREW CADDIE MIK SMALL HOHMANN RETRACTOR Handle Assembly TUBERCLE ARM ZUK DISTAL TELESCOPING ROD Solar Reference Frame Left LATITUDE QLS REVISION CASE - UNIVERSAL NATURAL IMPLANT HOLDER RO 2/4 MM TIB DEPTH RES STYLUS Affiniti Glenoid Instrument kit CFP QUICK LAUNCH 1 LAG SCREW CADDY AFP QL Screw Caddy AFFINITI EH2 56MM TUBEROSITY REAMER Trident Forceps, Malleollar N-K II PROXIMAL TIBIA ALI Navigation Restoration Modular Other Hip Affiniti Humeral Bottom Tray Ascend Modular Core Instrument Case TRAY ASSY, COMPRESSION PIN AFFINITI EH2 48MM TUBEROSITY REAMER HTO "Z" RETRACTOR MACHINE ROTATING PLATFORM BP TRIA NATURAL IMPLANT HOLDER Wave Locking Screw Caddy LATITUDE EV INSTRUMENT CASE LID LID FOR NCP CASE STABILIS STERILIZATION TRAY, ASSEMBLY ElbowLoc HRIS System DJO Surgical Patella Inserter Chamfer Tool Tray DISTAL FEM RES HOLDING PEG DJO Surgical Reamer Guide Pin LATITUDE EV INSTRUMENT CASE 2 UNIVERSAL HEAD IMPACTOR SLOTTED VARUS/VALGUS CUT AFFINITI GLENOID CASE ASSEMBLY DVO MLFX INTRAFOCAL PIN PLATE SYSTEM WAVE CASE BASE Wave Non Locking Fully Threaded Screw Caddy Aequalis Humeral Nail kitted Case Affiniti Humeral Lid SCP Graduated Guided Pin HTO DEPTH GAUGE ASSY MI KNEE RETACTOR Wave Plate Locking Screw Caddy Insert T-HANDLE ZIMMER CHUCK ArthroCare, Parasorb, Tray HEAD-NECK INSERTER HANDLE

Establishment Types

Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)