# Techfit Digital Surgery, Inc.

- Location (FDA's records): Daytona Beach, FL
- FDA decisions: 5 (2022–2025): 5 510(k) clearances
- Names in FDA's records: Techfit Digital Surgery, Inc. (4); Techfit Digital Surgery (1)
- Product codes: DZJ (2), HRS (1), LLZ (1), GWO (1)
- 510(k) review time since 2016: median 134 days, against 144 for FDA's reviews in the same codes and years (2 of 3 faster)
- Predicates its devices cite: 11 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- KLS-Martin L.P.: 2 (https://510kreport.com/company/kls-martin)
- Industrias Medicas Sampedro S.A.S: 2 (https://510kreport.com/company/industrias-medicas-sampedro)
- Synthes (Usa): 2 (https://510kreport.com/company/synthes-usa)
- Nobel Biocare AB: 1 (https://510kreport.com/company/nobel-biocare)
- Aap Implantate AG: 1 (https://510kreport.com/company/aap-implantate)
- Tdm Co., Ltd.: 1 (https://510kreport.com/company/tdm)
- Stryker Trauma AG: 1 (https://510kreport.com/company/stryker-trauma)
- Materialise NV: 1 (https://510kreport.com/company/materialise)

## Recent decisions
- K250297: TECHFIT Patient-Specific Cranial System (Oct 27, 2025)
- K242263: TECHFIT DISRP® System (Dec 11, 2024)
- K230276: TECHFIT DISRP® System (Jun 23, 2023)
- K222577: TECHFIT Diagnostic Models (Jan 6, 2023)
- K220199: AFFINITY Proximal Tibia System (Mar 21, 2022)

Source page: https://510kreport.com/company/techfit-digital-surgery