FDA applicant
Ace Medical Co.
FDA records 22 decisions for Ace Medical Co. (Los Angeles, CA) from 1987 to 2020: 22 510(k) clearances. Most are in product codes HWC (Screw, Fixation, Bone) and HRS (Plate, Fixation, Bone). Its devices cite 2 predicates, 0 of them its own earlier devices. 2 recalls are linked to its devices.
FDA’s records also spell it “Ace Medical”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Ace Medical Co.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2020
2026 so far, outlined.
Recalls per year
2in 2018
Class I Class II/III not classified
Planning a device like Ace Medical Co.’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