Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161
K-Number: K201072 · 2020-12-02
ApplicantEnsemble Orthopedics, LLC
Decision Date2020-12-02
Product CodeKYI
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161 is a medical device manufactured by Ensemble Orthopedics, LLC. It received FDA 510(k) clearance on 2020-12-02 under approval number K201072. The device is classified under product code KYI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161?
Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161 is a medical device that received FDA 510(k) clearance on 2020-12-02. It is manufactured by Ensemble Orthopedics, LLC. The 510(k) number is K201072.
When was Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161 approved by the FDA?
Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161 received FDA 510(k) clearance on 2020-12-02, under approval number K201072.
What company makes Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161?
Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161 is manufactured by Ensemble Orthopedics, LLC.
What is the FDA product code for Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161?
The FDA product code for Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161 is KYI.
Related Devices (Code: KYI)
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.