K201287 is an FDA 510(k) clearance for the Impulse Interbody Fusion System. This device is classified as a Intervertebral Fusion Device With Bone Graft, Lumbar (Class II - Special Controls, product code MAX).
Submitted by Degen Medical (Florence, US). The FDA issued a Cleared decision on December 22, 2020, 222 days after receiving the submission on May 14, 2020.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3080. Intended To Stabilize Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft..
| 510(k) Number | K201287 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 14, 2020 |
| Decision Date | December 22, 2020 |
| Days to Decision | 222 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | MAX — Intervertebral Fusion Device With Bone Graft, Lumbar |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3080 |
| Definition | Intended To Stabilize Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft. |