FDA applicant
Spine Wave, Inc.
FDA records 59 decisions for Spine Wave, Inc. (Shelton, CT) from 2004 to 2026: 59 510(k) clearances. Most are in product codes MAX (Intervertebral Fusion Device With Bone Graft…) and MNI (Orthosis, Spinal Pedicle Fixation). Since 2016 its 510(k)s took a median of 82 days from receipt to decision, against 95 for FDA’s reviews in the same codes and years. Its devices cite 142 predicates, 76 of them its own earlier devices. 2 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Spine Wave, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
3in 2025
2026 so far, outlined.
Recalls per year
1in 2013
Class I Class II/III not classified
Planning a device like Spine Wave, 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) Report