The Optimotion Blue Plus Knee System
K-Number: K240938 · 2024-06-27
ApplicantOptimotion Implants, LLC
Decision Date2024-06-27
Product CodeMBH
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
The Optimotion Blue Plus Knee System is a medical device manufactured by Optimotion Implants, LLC. It received FDA 510(k) clearance on 2024-06-27 under approval number K240938. The device is classified under product code MBH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the The Optimotion Blue Plus Knee System?
The Optimotion Blue Plus Knee System is a medical device that received FDA 510(k) clearance on 2024-06-27. It is manufactured by Optimotion Implants, LLC. The 510(k) number is K240938.
When was The Optimotion Blue Plus Knee System approved by the FDA?
The Optimotion Blue Plus Knee System received FDA 510(k) clearance on 2024-06-27, under approval number K240938.
What company makes The Optimotion Blue Plus Knee System?
The Optimotion Blue Plus Knee System is manufactured by Optimotion Implants, LLC.
What is the FDA product code for The Optimotion Blue Plus Knee System?
The FDA product code for The Optimotion Blue Plus Knee System is MBH.
Other Devices by Optimotion Implants, LLC
Related Devices (Code: MBH)
K162256Klassic Femur, Porous, Klassic Tibial Baseplate, PorousTotal Joint Orthopedics, Inc.
K153657Vanguard XP Knee SystemBiomet, Inc.
K153776Optetrak One Logic Femoral ComponentsExactech, Inc.
K153586Arthrex iBalance TKA SystemArthrex, Inc.
K172634Triathlon® X3® UHMWPE Tibial Inserts and Patellar ComponentsHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics
K171365Arthrex Knee SystemsArthrex, Inc.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.