Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161— 510(k) K201072
Substantially EquivalentEnsemble Orthopedics, LLC
FDA 510(k) clearance K201072 for Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161, Substantially Equivalent on 2020-12-02. Applicant: Ensemble Orthopedics, LLC. Device class: 2.
Clearance details
- Applicant
- Ensemble Orthopedics, LLC
- Product code
- Code KYI
- Device class
- Class 2
- Regulation
- 21 CFR 888.3770
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Austin, TX, US
Recent devices under product code KYI
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