Engage Partial Knee System— 510(k) K190439

Substantially Equivalent

Engage Uni, LLC

FDA 510(k) clearance K190439 for Engage Partial Knee System, Substantially Equivalent on 2019-11-21. Applicant: Engage Uni, LLC.

Clearance details

Applicant: Engage Uni, LLC
Product code: Code NJD
Advisory panel: Orthopedic
Date received: 2019-02-25
Decision date: 2019-11-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Winter Park, FL, US

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