FDA device listing
278-1-10004,5901IT01 Tornier Perform Advanced Glenoid Inlay Impactor Tip,5901IT02 Tornier Perform Advanced Glenoid Onlay…
FDA device listing 1761505837 · Straits Orthopaedics (Mfg) Sdn Bhd
Key facts
| Proprietary names | 278-1-10004,5901IT01 Tornier Perform Advanced Glenoid Inlay Impactor Tip,5901IT02 Tornier Perform Advanced Glenoid Onlay Impactor Tip,803-15-001 (Straight Acet, Impactor, Empowr),ADVANCE® II TIB BASE EXT/IMP NEW - REPLACING K0027224 (K0027227),Altivate Anatomic™ Cannulated Impactor (804-07-136),CUP IMPACTOR ADAPTER "PROCOTYL® L / O" SIZE GROUP A (APA09303),CUP IMPACTOR ADAPTER "PROCOTYL® L / O"… |
|---|---|
| Owner/operator | Straits Orthopaedics (Mfg) Sdn Bhd |
| Owner/operator number | 10048319 |
| Product codes | HWA |
| Device names | HWA - Impactor |
| Device class | Class I |
| Classification regulations (21 CFR) | 888.4540 |
| Review panels | Orthopedic |
| Registered establishments | STRAITS ORTHOPAEDICS (MFG) SDN BHD |
| Establishment registrations | 3025603301, 3033509898, 3036756245 |
| FEI numbers | 3025603301, 3033509898, 3036756245 |
| 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