FDA applicant
Tyber Medical, LLC
FDA records 31 decisions for Tyber Medical, LLC (Bethlehem, PA) from 2013 to 2026: 31 510(k) clearances. Most are in product codes HRS (Plate, Fixation, Bone) and HWC (Screw, Fixation, Bone). Since 2016 its 510(k)s took a median of 90 days from receipt to decision, against 110 for FDA’s reviews in the same codes and years. Its devices cite 84 predicates, 40 of them its own earlier devices. 20 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Tyber Medical, LLC’s devices, and how often a recall has named them.
FDA decisions per year
4in 2025
2026 so far, outlined.
Recalls per year
20in 2025
Class I Class II/III not classified
Planning a device like Tyber Medical, LLC’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