FDA applicant
Alphatec Spine, Inc.
FDA records 102 decisions for Alphatec Spine, Inc. (Carlsbad, CA) from 2005 to 2026: 102 510(k) clearances. Most are in product codes MAX (Intervertebral Fusion Device With Bone Graft…) and NKB (Thoracolumbosacral Pedicle Screw System). Since 2016 its 510(k)s took a median of 63 days from receipt to decision, against 91 for FDA’s reviews in the same codes and years. Its devices cite 357 predicates, 182 of them its own earlier devices. 47 recalls are linked to its devices.
FDA’s records also spell it “Alphatec Spine”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Alphatec Spine, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
5in 2025
2026 so far, outlined.
Recalls per year
3in 2026
Class I Class II/III not classified
Planning a device like Alphatec Spine, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Alphatec”
FDA records each applicant name separately; these may or may not be the same firm.