Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K133842
TYBER MEDICAL TRAUMA SCREW · Tyber Medical, LLC · decided 2014-03-20 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| ORION | HTR-04-450730 | HNM TOTAL RECON LLC | HWC | 00841742118918 |
| Cannulated Compression Headless Screw | 04.333.765TS | Tyber Medical, LLC | HWC | 00819917029963 |
| Cannulated Compression Headless Screw | 04.333.238TS | Tyber Medical, LLC | HWC | 00819917027556 |
| Cannulated Compression Headless Screw | 04.333.116TS | Tyber Medical, LLC | HWC | 00819917027174 |
| Cannulated Compression Headless Screw | 04.333.646 | Tyber Medical, LLC | HWC | 00819917025200 |
| Cannulated Compression Headless Screw | 04.334.545 | Tyber Medical, LLC | HWC | 00819917024890 |
| Cannulated Compression Headless Screw | 04.333.536 | Tyber Medical, LLC | HWC | 00819917024593 |
| Cannulated Compression Headless Screw | 04.333.524 | Tyber Medical, LLC | HWC | 00819917024524 |
| Cannulated Compression Headless Screw | 04.334.442 | Tyber Medical, LLC | HWC | 00819917024401 |
| Cannulated Compression Headless Screw | 04.333.436 | Tyber Medical, LLC | HWC | 00819917024180 |
| Cannulated Compression Headless Screw | 04.334.126 | Tyber Medical, LLC | HWC | 00819917023404 |
| Cannulated Compression Headless Screw | 04.334.540S | Tyber Medical, LLC | HWC | 00810080882690 |
| Cannulated Compression Headless Screw | 04.334.348S | Tyber Medical, LLC | HWC | 00810080882393 |
| Cannulated Compression Headless Screw | 1ZB804115 | Tyber Medical, LLC | HWC | 00810030823148 |
| Cannulated Compression Headless Screw | 04.334.358TS | Tyber Medical, LLC | HWC | 00196449008315 |
| (unnamed) | M1-652115 | Tyber Medical, LLC | HWC | M695M16521150 |
| (unnamed) | M1-652100 | Tyber Medical, LLC | HWC | M695M16521000 |
| (unnamed) | M1-45444 | Tyber Medical, LLC | HWC | M695M1454440 |
| (unnamed) | M1-45232 | Tyber Medical, LLC | HWC | M695M1452320 |
| (unnamed) | M1-30228 | Tyber Medical, LLC | HWC | M695M1302280 |
| (unnamed) | M1-30222 | Tyber Medical, LLC | HWC | M695M1302220 |
| (unnamed) | M1-30221 | Tyber Medical, LLC | HWC | M695M1302210 |
| Tyber Medical | Headless Ø3.0 x 32mm Short Thread Ti (Torx) | Tyber Medical, LLC | HWC | M695401302321W |
| Tyber Medical | Headless Ø2.0 x 28mm Full Thread Ti (Torx) | Tyber Medical, LLC | HWC | M695401204281 |
| Tyber Medical | Headless Ø2.0 x 19mm Full Thread Ti (Torx) | Tyber Medical, LLC | HWC | M695401204191 |