K180480 is an FDA 510(k) clearance for the ATEC 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, Inc. (Carlsnad, US). The FDA issued a Cleared decision on May 31, 2018, 97 days after receiving the submission on February 23, 2018.
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 | K180480 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 23, 2018 |
| Decision Date | May 31, 2018 |
| Days to Decision | 97 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. |