# Industrias Medicas Sampedro S.A.S

- Location (FDA's records): La Estrella, CO
- FDA decisions: 2 (2019–2021): 2 510(k) clearances
- Product codes: JEY (1), HRS (1)
- Predicates its devices cite: 2 (0 its own); citations of its devices by later devices: 4 (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.: 1 (https://510kreport.com/company/kls-martin)
- Stryker Corp.: 1 (https://510kreport.com/company/stryker)

## Firms that cite its devices most
- Techfit Digital Surgery, Inc.: 2 (https://510kreport.com/company/techfit-digital-surgery)
- Orthonovis, Inc.: 2 (https://510kreport.com/company/orthonovis)

## Its most-cited devices
- K191641: AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle Distal Radius Plates, AFFINITY – Variable Angle Distal Radius Screws (2019), cited by 3
- K203282: TECHFIT Patient-Specific Maxillofacial System (2021), cited by 1

## Recent decisions
- K203282: TECHFIT Patient-Specific Maxillofacial System (May 19, 2021)
- K191641: AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle Distal Radius Plates, AFFINITY – Variable Angle Distal Radius Screws (Sep 16, 2019)

Source page: https://510kreport.com/company/industrias-medicas-sampedro