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Alphatec Spine

FDA 510(k) & PMA Approved Devices — 6 products

Total Devices6
Categories5
Latest FDA decision2025-09-03
TypeNumberDevice NameCodeDateActions
510(k) K251575 IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemOVD2025-09-03 View
510(k) K241375 IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi Cervical Porous Ti Interbody System; IdentiTi NanoTec Cervical Interbody System; IdentiTi Cervical Standalone Interbody System; IdentiTi NanoTec Cervical Standalone Interbody System; IdentiTi ALIF Standalone Interbody System; IdentiTi NanoTec ALIF Standalone Interbody System; Transcend PEEK Interbody System; Transcend NanoTec Interbody System; Transcend Cervical PEEK Interbody System; Transcend NanoTec CerMAX2025-02-03 View
510(k) K240951 Invictus Robotic Navigation InstrumentsOLO2024-06-06 View
510(k) K222028 IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™ PEEK Interbody System, Transcend™ NanoTec™ Interbody System, IdentiTi™ ALIF Standalone Interbody System, IdentiTi™ NanoTec™ ALIF Standalone Interbody SystemMAX2022-10-07 View
510(k) K191185 Solanas® Posterior OCT Fixation SystemNKG2019-06-03 View
510(k) K160958 Battalion Universal Spacer SystemPHM2016-09-08 View
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