FDA 510(k) Applications Submitted by Andrew Zhang
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K220782 |
03/17/2022 |
IdentiTiÖ Porous Ti Interbody System, IdentiTiÖ NanoTecÖ Interbody System, TranscendÖ PEEK Interbody System, TranscendÖ NanoTecÖ Interbody System, IdentiTiÖ ALIF Standalone Interbody System, IdentiTiÖ NanoTecÖ ALIF Standalone Interbody System, IdentiTiÖ C |
Alphatec Spine, Inc. |
| K241519 |
05/29/2024 |
Invictus« Small Stature Spinal Fixation System |
Alphatec Spine, Inc. |
| K232097 |
07/13/2023 |
IdentiTi ALIF Interbody Systems |
Alphatec Spine, Inc. |
| K222973 |
09/28/2022 |
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 Interb |
Alphatec Spine Inc. |
| K243461 |
11/08/2024 |
Calibrate Interbody Systems |
Alphatec Spine, Inc. |
| K233640 |
11/13/2023 |
Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS Interbody System; Transcend SPS Interbody System;Transcend NanoTec SPS Interbody System |
Alphatec Spine Inc. |
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