United Orthopedic Knee Patient Specific Instrumentation— 510(k) K230850

Substantially Equivalent

Enhatch, Inc.

FDA 510(k) clearance K230850 for United Orthopedic Knee Patient Specific Instrumentation, Substantially Equivalent on 2023-12-20. Applicant: Enhatch, Inc..

Clearance details

Applicant: Enhatch, Inc.
Product code: Code OOG
Advisory panel: Orthopedic
Date received: 2023-03-28
Decision date: 2023-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hasbrouck Heights, NJ, 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.