FDA device listing
Acufex Director Anatomic ACL Tray,Crosstrac Hip Guide System Tray,Multi-Purpose Sterilization Tray
FDA device listing 1298409810 · Tecomet
Key facts
| Proprietary names | Acufex Director Anatomic ACL Tray,Crosstrac Hip Guide System Tray,Multi-Purpose Sterilization Tray |
|---|---|
| Owner/operator | Tecomet |
| Owner/operator number | 1828464 |
| Product codes | KCT |
| Device names | KCT - Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Device class | Class II |
| Classification regulations (21 CFR) | 880.6850 |
| Review panels | General Hospital |
| Registered establishments | SYMMETRY MEDICAL, INC. - MANCHESTER |
| Establishment registrations | 1221053 |
| FEI numbers | 1221053 |
| 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