Libra Pedicle Screw System
FDA 510(k) clearance K162750 · decided 2016-10-27
Clearance details
- K-number
- K162750
- Device name
- Libra Pedicle Screw System
- Applicant
- Spinal Balance, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2016-09-30
- Decision date
- 2016-10-27
- Days to decision
- 27 days
- Clearance type
- Special
- Product code
- NKB
- Device class
- 2
- Regulation number
- 888.3070
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Toledo, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.