# Alphatec Spine, Inc.

- Location (FDA's records): Carlsbad, CA
- FDA decisions: 102 (2005–2026): 102 510(k) clearances
- Names in FDA's records: Alphatec Spine, Inc. (96); Alphatec Spine (6)
- Product codes: MAX (22), NKB (20), KWQ (9), OLO (7), MNI (6), OVD (5), KWP (4), ODP (4), MNH (3), NKG (3), PDQ (3), GWF (3)
- 510(k) review time since 2016: median 63 days, against 91 for FDA's reviews in the same codes and years (41 of 59 faster)
- Predicates its devices cite: 357 (182 its own); citations of its devices by later devices: 283 (182 its own)
- Recalls linked to its devices: 47 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Nu Vasive, Incorporated: 22 (https://510kreport.com/company/nu-vasive)
- Alphatec/Nexmed: 14 (https://510kreport.com/company/alphatec-nexmed)
- Globus Medical, Inc.: 11 (https://510kreport.com/company/globus-medical)
- Medtronic Sofamor Danek USA, Inc.: 9 (https://510kreport.com/company/medtronic-sofamor-danek-usa)
- Alphatec Mfg., Inc.: 7 (https://510kreport.com/company/alphatec-mfg)
- Medtronic Sofamor Danek: 6 (https://510kreport.com/company/medtronic-sofamor-danek)
- Depuyacromed: 4 (https://510kreport.com/company/depuyacromed)
- Medos International SARL: 4 (https://510kreport.com/company/medos-international)

## Firms that cite its devices most
- Spineology, Inc.: 5 (https://510kreport.com/company/spineology)
- Nu Vasive, Incorporated: 4 (https://510kreport.com/company/nu-vasive)
- Camber Spine Technologies: 4 (https://510kreport.com/company/camber-spine-technologies)
- Life Spine, Inc.: 3 (https://510kreport.com/company/life-spine)
- Choicespine, LP: 3 (https://510kreport.com/company/choicespine)
- Evolution Spine: 3 (https://510kreport.com/company/evolution-spine)
- Degen Medical: 3 (https://510kreport.com/company/degen-medical)
- Kalitec Direct, LLC: 3 (https://510kreport.com/company/kalitec-direct)

## Its most-cited devices
- K183705: IdentiTi Porous Ti Interbody System (2019), cited by 16
- K081730: Novel Cervical Spinal Spacer System (2008), cited by 16
- K180480: ATEC Universal Spacer System (2018), cited by 11
- K080699: Novel Spinal Spacer System (2008), cited by 11
- K071890: Zodiac 4.0 Polyaxial Spinal Fixation System (2007), cited by 11
- K161363: Arsenal Spinal Fixation System (2016), cited by 9

## Recent decisions
- K262646: Calibrate MAX System; Calibrate NanoTec MAX System; Calibrate CCX Interbody System; Calibrate NanoTec CCX Interbody System (Oct 21, 2026)
- K261284: Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System (Jul 14, 2026)
- K253216: IntraOp Alignment System; CONTOUR3D Bending System (Jun 25, 2026)
- K253615: Invictus Bands System (Mar 25, 2026)
- K252597: Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation) (Feb 19, 2026)
- K252842: SafeOp 3: Neural Informatix System (Jan 11, 2026)
- K251575: IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody System (Sep 3, 2025)
- K251965: Proximity Anterior Cervical Plate System; Segmental Plating System (SPS) (Aug 28, 2025)

Source page: https://510kreport.com/company/alphatec-spine