510(k) K131321
K131321 is an FDA 510(k) premarket notification submitted by Medtronic Sofamor Danek USA for the device "CD HORIZON SPINAL SYSTEM". The FDA issued a decision of Substantially Equivalent on June 5, 2013. The device falls under product code OSH (Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis), a Class II device regulated under 21 CFR 888.3070. Medtronic Sofamor Danek USA has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 5, 2013
- Date Received
- May 8, 2013
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis
- Device Class
- Class II
- Regulation Number
- 888.3070
- Review Panel
- OR
- Submission Type
Intended to stabilize the thoracolumbar spine as an adjunct to fusion using allograft and/or autograft to treat adolescent idiopathic scoliosis.