FDA applicant
Medtronic Sofamor Danek USA, Inc.
FDA records 188 decisions for Medtronic Sofamor Danek USA, Inc. (Memphis, TN) from 2000 to 2026: 184 510(k) clearances and 4 original PMA approvals. Most are in product codes NKB (Thoracolumbosacral Pedicle Screw System) and MAX (Intervertebral Fusion Device With Bone Graft…). Since 2016 its 510(k)s took a median of 86 days from receipt to decision, against 93 for FDA’s reviews in the same codes and years. Its devices cite 715 predicates, 314 of them its own earlier devices. 31 recalls are linked to its devices.
FDA’s records also spell it “Medtronic Sofamor Danek USA”, “Medtronic Sofamor Danek USA, Incorporated”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Medtronic Sofamor Danek USA, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
5in 2025
2026 so far, outlined.
Recalls per year
1in 2025
Class I Class II/III not classified
Planning a device like Medtronic Sofamor Danek USA, 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