FDA applicant
Linvatec Corp.
FDA records 93 decisions for Linvatec Corp. (Largo, FL) from 1992 to 2009: 93 510(k) clearances. Most are in product codes HRX (Arthroscope) and HWC (Screw, Fixation, Bone). Its devices cite 82 predicates, 38 of them its own earlier devices. 15 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Linvatec Corp.’s devices, and how often a recall has named them.
FDA decisions per year
5in 2009
2026 so far, outlined.
Recalls per year
1in 2017
Class I Class II/III not classified
Planning a device like Linvatec Corp.’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 “Linvatec”
FDA records each applicant name separately; these may or may not be the same firm.