ACTERA hip system— 510(k) K231178

Substantially Equivalent

Conformis, Inc.

FDA 510(k) clearance K231178 for ACTERA hip system, Substantially Equivalent on 2023-05-23. Applicant: Conformis, Inc..

Clearance details

Applicant: Conformis, Inc.
Product code: Code MEH
Advisory panel: Orthopedic
Date received: 2023-04-26
Decision date: 2023-05-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Billerica, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MEH

product code MEH

Injury: 2,021
Total: 2,021

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.