K170830 is an FDA 510(k) clearance for the Unison-C Anterior Cervical Fixation System. This device is classified as a Intervertebral Fusion Device With Integrated Fixation, Cervical (Class II - Special Controls, product code OVE).
Submitted by Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) (Marquette, US). The FDA issued a Cleared decision on June 28, 2017, 100 days after receiving the submission on March 20, 2017.
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 | K170830 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 20, 2017 |
| Decision Date | June 28, 2017 |
| Days to Decision | 100 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. |