FDA applicant
Depuy Mitek, Inc., A Johnson and Johnson Company
FDA records 6 decisions for Depuy Mitek, Inc., A Johnson and Johnson Company (Raynham, MA) from 2012 to 2015: 6 510(k) clearances. Most are in product codes MBI (Fastener, Fixation, Nondegradable, Soft Tissue) and MAI (Fastener, Fixation, Biodegradable, Soft Tissue). Its devices cite 19 predicates, 0 of them its own earlier devices. 5 recalls are linked to its devices.
FDA’s records also spell it “Depuy Mitek, A Johnson and Johnson Company”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Depuy Mitek, Inc., A Johnson and Johnson Company’s devices, and how often a recall has named them.
FDA decisions per year
1in 2015
2026 so far, outlined.
Recalls per year
5in 2023
Class I Class II/III not classified
Planning a device like Depuy Mitek, Inc., A Johnson and…’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.