K122571 is an FDA 510(k) clearance for the MALIBU SPINAL SYSTEM WITH THE DAYTONA DEFORMITY SYSTEM. This device is classified as a Thoracolumbosacral Pedicle Screw System (Class II - Special Controls, product code NKB).
Submitted by Seaspine, Inc. (Vista, US). The FDA issued a Cleared decision on December 12, 2012, 111 days after receiving the submission on August 23, 2012.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3070. Intended To Provide Immobilization And Stabilization Of Spinal Segments In Thoracic, Lumbar, And Sacral Spine As An Adjunct To Fusion..
| 510(k) Number | K122571 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 23, 2012 |
| Decision Date | December 12, 2012 |
| Days to Decision | 111 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | NKB — Thoracolumbosacral Pedicle Screw System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3070 |
| Definition | Intended To Provide Immobilization And Stabilization Of Spinal Segments In Thoracic, Lumbar, And Sacral Spine As An Adjunct To Fusion. |