K160958 is an FDA 510(k) clearance for the Battalion Universal Spacer System. This device is classified as a Intervertebral Fusion Device With Bone Graft, Thoracic (Class II - Special Controls, product code PHM).
Submitted by Alphatec Spine (Carlsnad, US). The FDA issued a Cleared decision on September 8, 2016, 156 days after receiving the submission on April 5, 2016.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3080. Intended To Stabilize Thoracic Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft..
| 510(k) Number | K160958 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 05, 2016 |
| Decision Date | September 08, 2016 |
| Days to Decision | 156 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | PHM - Intervertebral Fusion Device With Bone Graft, Thoracic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3080 |
| Definition | Intended To Stabilize Thoracic Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft. |