FDA applicant
Innovasis, Inc.
FDA records 35 decisions for Innovasis, Inc. (Salt Lake City, UT) from 2004 to 2025: 35 510(k) clearances. Most are in product codes MAX (Intervertebral Fusion Device With Bone Graft…) and ODP (Intervertebral Fusion Device With Bone Graft…). Since 2016 its 510(k)s took a median of 91 days from receipt to decision, against 105 for FDA’s reviews in the same codes and years. Its devices cite 89 predicates, 34 of them its own earlier devices. 7 recalls are linked to its devices.
FDA’s records also spell it “Innovasis”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Innovasis, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
4in 2025
2026 so far, outlined.
Recalls per year
1in 2026
Class I Class II/III not classified
Planning a device like Innovasis, 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