NextAR TKA Platform— 510(k) K202152
Substantially EquivalentMedacta International S.A.
FDA 510(k) clearance K202152 for NextAR TKA Platform, Substantially Equivalent on 2020-10-27. Applicant: Medacta International S.A.. Device class: 2.
Clearance details
- Applicant
- Medacta International S.A.
- Product code
- Code SBF
- Device class
- Class 2
- Regulation
- 21 CFR 882.4560
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Castel San Pietro (Ch), CH
Recent devices under product code SBF
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