AFFINITY Variable Angle Distal Radius System, AFFINITY Variable Angle Distal Radius Plates, AFFINITY Variable Angle Distal Radius Screws— 510(k) K191641

Name: FDA 510(k) clearance K191641
Creator: U.S. Food and Drug Administration
Published: 2019-09-16

Substantially Equivalent

Industrias Medicas Sampedro S.A.S

FDA 510(k) clearance K191641 for AFFINITY Variable Angle Distal Radius System, AFFINITY Variable Angle Distal Radius Plates, AFFINITY Variable Angle Distal Radius Screws, Substantially Equivalent on 2019-09-16. Applicant: Industrias Medicas Sampedro S.A.S. Device class: 2.

Clearance details

Applicant: Industrias Medicas Sampedro S.A.S
Product code: Code HRS
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2019-06-19
Decision date: 2019-09-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: La Estrella, CO

Download summary PDF View on FDA.gov ↗

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Adverse events under product code HRS

product code HRS

Death: 27
Injury: 10,340
Malfunction: 3,328
Total: 13,695

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.