UNIKO PointCloud Knee Instruments— 510(k) K193312

Substantially Equivalent

Unik Orthopedics, Inc.

FDA 510(k) clearance K193312 for UNIKO PointCloud Knee Instruments, Substantially Equivalent on 2020-08-12. Applicant: Unik Orthopedics, Inc..

Clearance details

Applicant: Unik Orthopedics, Inc.
Product code: Code MBH
Advisory panel: Orthopedic
Date received: 2019-11-29
Decision date: 2020-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MBH

product code MBH

Injury: 6,545
Malfunction: 2,023
Total: 8,568

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.