MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides
FDA 510(k) clearance K220888 · decided 2022-05-24
Clearance details
- K-number
- K220888
- Device name
- MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides
- Applicant
- Medacta International S.A.
- Decision
- Substantially Equivalent
- Date received
- 2022-03-28
- Decision date
- 2022-05-24
- Days to decision
- 57 days
- Clearance type
- Traditional
- Product code
- QSR
- Device class
- 2
- Regulation number
- 888.3040
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Castel San Pietro (Ch), CH
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.