FDA applicant
Medtronic Sofamor Danek
FDA records 255 decisions for Medtronic Sofamor Danek (Memphis, TN) from 2000 to 2025: 253 510(k) clearances and 2 original PMA approvals. Most are in product codes NKB (Thoracolumbosacral Pedicle Screw System) and KWP (Appliance, Fixation, Spinal Interlaminal). Since 2016 its 510(k)s took a median of 66 days from receipt to decision, against 106 for FDA’s reviews in the same codes and years. Its devices cite 519 predicates, 285 of them its own earlier devices. 64 recalls are linked to its devices.
FDA’s records also spell it “Medtronic Sofamor Danek, Inc.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Medtronic Sofamor Danek’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
1in 2020
Class I Class II/III not classified
Planning a device like Medtronic Sofamor Danek’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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