The following data is part of a premarket notification filed by Alphatec Spine Inc. with the FDA for Identiti And Transcend Interbody Systems: Indentiti Cervical Porous Ti Interbody System, Identiti Nanotec Cervical Interbody System, Transcend Cervical Peek Interbody System, Transcend Nanotec Cervical Interbody System, Identiti Cervical Standalone I.
| Device ID | K222973 |
| 510k Number | K222973 |
| Device Name: | IdentiTi And Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System, IdentiTi NanoTec Cervical Interbody System, Transcend Cervical PEEK Interbody System, Transcend NanoTec Cervical Interbody System, IdentiTi Cervical Standalone I |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | Alphatec Spine Inc. 1950 Camino Vida Roble Carlsbad, CA 92008 |
| Contact | Andrew Zhang |
| Correspondent | Andrew Zhang Alphatec Spine Inc. 1950 Camino Vida Roble Carlsbad, CA 92008 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-09-28 |
| Decision Date | 2022-11-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00190376475349 | K222973 | 000 |
| 00190376538815 | K222973 | 000 |
| 00190376539287 | K222973 | 000 |
| 00190376539294 | K222973 | 000 |
| 00190376544823 | K222973 | 000 |
| 00190376555874 | K222973 | 000 |
| 00190376560281 | K222973 | 000 |
| 00190376560298 | K222973 | 000 |
| 00190376560304 | K222973 | 000 |
| 00190376560311 | K222973 | 000 |
| 00190376475271 | K222973 | 000 |
| 00190376475288 | K222973 | 000 |
| 00190376475295 | K222973 | 000 |
| 00190376475301 | K222973 | 000 |
| 00190376475318 | K222973 | 000 |
| 00190376475325 | K222973 | 000 |
| 00190376475332 | K222973 | 000 |
| 00190376538808 | K222973 | 000 |