K231704 is an FDA 510(k) clearance for the Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer System. This device is classified as a Intervertebral Fusion Device With Integrated Fixation, Cervical (Class II - Special Controls, product code OVE).
Submitted by Life Spine, Inc. (Huntley, US). The FDA issued a Cleared decision on October 19, 2023, 129 days after receiving the submission on June 12, 2023.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3080. Intended To Stabilize Cervical Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft With Or Without Supplemental Fixation..
| 510(k) Number | K231704 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 12, 2023 |
| Decision Date | October 19, 2023 |
| Days to Decision | 129 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | OVE — Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3080 |
| Definition | Intended To Stabilize Cervical Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft With Or Without Supplemental Fixation. |