K150380 is an FDA 510(k) clearance for the ProMIS Fixation System. This device is classified as a Thoracolumbosacral Pedicle Screw System (Class II - Special Controls, product code NKB).
Submitted by Premia Spine, Ltd. (Ramat Poleg, IL). The FDA issued a Cleared decision on July 17, 2015, 154 days after receiving the submission on February 13, 2015.
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 | K150380 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 13, 2015 |
| Decision Date | July 17, 2015 |
| Days to Decision | 154 days |
| Submission Type | Traditional |
| 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. |