FDA applicant
Corin USA
FDA records 79 decisions for Corin USA (Tampa, FL) from 1996 to 2025: 78 510(k) clearances and 1 original PMA approval. Most are in product codes LZO (Prosthesis, Hip, Semi-Constrained…) and JWH (Prosthesis, Knee, Patellofemorotibial…). Since 2016 its 510(k)s took a median of 167 days from receipt to decision, against 116 for FDA’s reviews in the same codes and years. Its devices cite 197 predicates, 116 of them its own earlier devices. 16 recalls are linked to its devices.
FDA’s records also spell it “Corin U.S.A. Limited”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Corin USA’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
2in 2023
Class I Class II/III not classified
Planning a device like Corin USA’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 “Corin”
FDA records each applicant name separately; these may or may not be the same firm.