Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle Screw System, Valencia MIS Pedicle Screw System
FDA 510(k) clearance K151648 · decided 2015-10-16
Clearance details
- K-number
- K151648
- Device name
- Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle Screw System, Valencia MIS Pedicle Screw System
- Applicant
- Altus Partners, LLC
- Decision
- Substantially Equivalent
- Date received
- 2015-06-18
- Decision date
- 2015-10-16
- Days to decision
- 120 days
- Clearance type
- Traditional
- Product code
- NKB
- Device class
- 2
- Regulation number
- 888.3070
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Newtown Square, PA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.