FDA applicant
Depuy Spine, Inc.
FDA records 73 decisions for Depuy Spine, Inc. (Raynham, MA) from 1999 to 2022: 71 510(k) clearances and 2 original PMA approvals. Most are in product codes NKB (Thoracolumbosacral Pedicle Screw System) and KWQ (Appliance, Fixation, Spinal Intervertebral Body). Its devices cite 268 predicates, 131 of them its own earlier devices. 17 recalls are linked to its devices.
FDA’s records also spell it “Depuy Spine”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Depuy Spine, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2022
2026 so far, outlined.
Recalls per year
7in 2016
Class I Class II/III not classified
Planning a device like Depuy 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) ReportOther applicant names beginning “Depuy”
FDA records each applicant name separately; these may or may not be the same firm.