FDA device listing
ARTIC/EZE TR BALL GRVD,Attune,Biomet Template,CHARLOTTE,Corail AMT Neck Seg,EXTENDED TIBIA JIG SPRING,GROOVED SMALL…
FDA device listing 1850445997 · Tecomet
Key facts
| Proprietary names | ARTIC/EZE TR BALL GRVD,Attune,Biomet Template,CHARLOTTE,Corail AMT Neck Seg,EXTENDED TIBIA JIG SPRING,GROOVED SMALL TAPER 32mm + 5 TRIAL HEAD,Integra surgical instrument,LCS,LOW PROFILE TIBIAL JIG,LOW PROFILE TIBIA TARGET ARM,Max 4 Size Patella Template,Modular Endo Heads,OFFSET TIB TRAY TRIAL,PAT RESECT GDE .060 SAWBLADE,PINN AB IN TR,PINNACLE TRIAL SHELL,Quickset Screw System,RECLAIM PROX TRIAL… |
|---|---|
| Owner/operator | Tecomet |
| Owner/operator number | 1828464 |
| Product codes | HWT |
| Device names | HWT - Template |
| Device class | Class I |
| Classification regulations (21 CFR) | 888.4800 |
| Review panels | Orthopedic |
| Registered establishments | SYMMETRY MEDICAL, INC. - MANCHESTER, SYMMETRY MEDICAL MANUFACTURING INC, SYMMETRY MEDICAL MANUFACTURING INC. |
| Establishment registrations | 1221053, 1828464, 3003791208, 3005061536 |
| FEI numbers | 1221053, 1828464, 3003791208, 3005061536 |
| Establishment operations | Contract Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database