FDA applicant
Wenzel Spine, Inc.
FDA records 10 decisions for Wenzel Spine, Inc. (Austin, TX) from 2010 to 2026: 10 510(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 163 days from receipt to decision, against 117 for FDA’s reviews in the same codes and years. Its devices cite 28 predicates, 7 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Wenzel Spine”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Wenzel Spine, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2010.
Planning a device like Wenzel 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) Report