FDA device listing
0 DEG CUT GUIDE,3 DEG CUT GUIDE,7 DEG CUT GUIDE,APR FEMORAL OSTEOTOMY GUI,BIOMET GUIDE, SURGICAL INSTRUMENT,BIOMET…
FDA device listing 1461714701 · Tecomet
Key facts
| Proprietary names | 0 DEG CUT GUIDE,3 DEG CUT GUIDE,7 DEG CUT GUIDE,APR FEMORAL OSTEOTOMY GUI,BIOMET GUIDE, SURGICAL INSTRUMENT,BIOMET SURGICAL GUIDE,Carpal Tunnel Release Instruments,CNVSN GD NK CONSTR PRI,Compress Instruments,Cut- Guide, Em Tibial MI,DARCO,DISTAL FEMORAL SAW GUIDE,DISTAL RE-CUT GUIDE,DJO Surgical Head Gage Plate,DJO Surgical MIKA Cut Guide,DJO Surgical MIKA Knee Guide,EXT ROT CUT GDE, LT MED/RT… |
|---|---|
| Owner/operator | Tecomet |
| Owner/operator number | 1828464 |
| Product codes | FZX |
| Device names | FZX - Guide, Surgical, Instrument |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4800 |
| Review panels | General & Plastic Surgery |
| Registered establishments | SYMMETRY MEDICAL, INC. - MANCHESTER, SYMMETRY MEDICAL MANUFACTURING INC, SYMMETRY MEDICAL MANUFACTURING INC. |
| Establishment registrations | 1221053, 1828464, 3005061536 |
| FEI numbers | 1221053, 1828464, 3005061536 |
| Establishment operations | Contract Manufacturer, 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