Accu-Joint Hemi Implant— 510(k) K200951

Substantially Equivalent

Accufix Surgical, Inc.

FDA 510(k) clearance K200951 for Accu-Joint Hemi Implant, Substantially Equivalent on 2020-12-08. Applicant: Accufix Surgical, Inc..

Clearance details

Applicant: Accufix Surgical, Inc.
Product code: Code KWD
Advisory panel: Orthopedic
Date received: 2020-04-09
Decision date: 2020-12-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Haven, CT, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KWD

product code KWD

Injury: 164
Total: 164

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.