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 | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2005-03-14 |
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)