FDA applicant
O'Tec Corp.
FDA records 23 decisions for O'Tec Corp. (Memphis, TN) from 1988 to 1994: 23 510(k) clearances. Most are in product codes KTT (Appliance, Fixation, Nail/Blade/Plate…) and HTY (Pin, Fixation, Smooth). No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided O'Tec Corp.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for O'Tec Corp. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like O'Tec 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) Report