FDA applicant
Techfit Digital Surgery, Inc.
FDA records 5 decisions for Techfit Digital Surgery, Inc. (Daytona Beach, FL) from 2022 to 2025: 5 510(k) clearances. Most are in product codes DZJ (Driver, Wire, And Bone Drill, Manual) and HRS (Plate, Fixation, Bone). Since 2016 its 510(k)s took a median of 134 days from receipt to decision, against 144 for FDA’s reviews in the same codes and years. Its devices cite 11 predicates, 0 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Techfit Digital Surgery”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Techfit Digital Surgery, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2022.
Planning a device like Techfit Digital Surgery, 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