MySpine Unilateral Guides— 510(k) K231483
Substantially EquivalentMedacta International S.A.
FDA 510(k) clearance K231483 for MySpine Unilateral Guides, Substantially Equivalent on 2023-07-21. Applicant: Medacta International S.A.. Device class: 2.
Clearance details
- Applicant
- Medacta International S.A.
- Product code
- Code PQC
- Device class
- Class 2
- Regulation
- 21 CFR 888.3070
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Castel San Pietro, CH
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More clearances from Medacta International S.A.
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