M.U.S.T. Pedicle Screw System
FDA 510(k) clearance K153664 · decided 2016-01-19
Clearance details
- K-number
- K153664
- Device name
- M.U.S.T. Pedicle Screw System
- Applicant
- Medacta International
- Decision
- Substantially Equivalent
- Date received
- 2015-12-21
- Decision date
- 2016-01-19
- Days to decision
- 29 days
- Clearance type
- Special
- Product code
- NKB
- Device class
- 2
- Regulation number
- 888.3070
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Castel San Pietro, CH
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.