FDA applicant
Titan Spine, LLC
FDA records 19 decisions for Titan Spine, LLC (Mequon, WI) from 2008 to 2020: 19 510(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 72 days from receipt to decision, against 92 for FDA’s reviews in the same codes and years. Its devices cite 96 predicates, 52 of them its own earlier devices. 6 recalls are linked to its devices.
FDA’s records also spell it “Titan Spine, Inc.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Titan Spine, LLC’s devices, and how often a recall has named them.
FDA decisions per year
1in 2020
2026 so far, outlined.
Recalls per year
4in 2021
Class I Class II/III not classified
Planning a device like Titan Spine, LLC’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 “Titan”
FDA records each applicant name separately; these may or may not be the same firm.