K101812 is an FDA 510(k) clearance for the CONSTRUX MINI PEEK SPACER SYSTEM. This device is classified as a Intervertebral Fusion Device With Bone Graft, Cervical (Class II - Special Controls, product code ODP).
Submitted by Orthofix, Inc. (Mckinney, US). The FDA issued a Cleared decision on September 27, 2010, 90 days after receiving the submission on June 29, 2010.
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..
| 510(k) Number | K101812 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 29, 2010 |
| Decision Date | September 27, 2010 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | ODP — Intervertebral Fusion Device With Bone Graft, 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. |