MySpine Pedicle Screw Placement Guides MC and Drill Pilot Instruments— 510(k) K173472
Substantially EquivalentMedacta International S.A.
FDA 510(k) clearance K173472 for MySpine Pedicle Screw Placement Guides MC and Drill Pilot Instruments, Substantially Equivalent on 2018-04-19. 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), CH
Recent devices under product code PQC
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- K200792 — MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides
- K181883 — FIREFLY® Midline Navigation Guide
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