Triathlon AS-1— 510(k) K203421

Substantially Equivalent

Conformis, Inc.

FDA 510(k) clearance K203421 for Triathlon AS-1, Substantially Equivalent on 2021-04-19. Applicant: Conformis, Inc..

Clearance details

Applicant: Conformis, Inc.
Product code: Code OOG
Advisory panel: Orthopedic
Date received: 2020-11-20
Decision date: 2021-04-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Billerica, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OOG

product code OOG

Injury: 153
Total: 153

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.