FDA applicant
Pega Medical, Inc.
FDA records 12 decisions for Pega Medical, Inc. (Laval, CA) from 2003 to 2022: 12 510(k) clearances. Most are in product codes HSB (Rod, Fixation, Intramedullary And Accessories) and HRS (Plate, Fixation, Bone). Since 2016 its 510(k)s took a median of 184 days from receipt to decision, against 122 for FDA’s reviews in the same codes and years. Its devices cite 33 predicates, 11 of them its own earlier devices. 9 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Pega Medical, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2022
2026 so far, outlined.
Recalls per year
1in 2024
Class I Class II/III not classified
Planning a device like Pega Medical, Inc.’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