K073285 is an FDA 510(k) clearance for the PEEK PREVAIL CERVICAL INTERBODY DEVICE. This device is classified as a Intervertebral Fusion Device With Integrated Fixation, Cervical (Class II - Special Controls, product code OVE).
Submitted by Medtronic Sofamor Danek USA, Inc. (Memphis, US). The FDA issued a Cleared decision on May 15, 2008, 174 days after receiving the submission on November 23, 2007.
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 | K073285 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 23, 2007 |
| Decision Date | May 15, 2008 |
| Days to Decision | 174 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. |