K071668 is an FDA 510(k) clearance for the ORTHOBIOM SPINAL SYSTEM. This device is classified as a Orthosis, Spinal Pedicle Fixation (Class II - Special Controls, product code MNI).
Submitted by Paradigm Spine (New York, US). The FDA issued a Cleared decision on July 2, 2008, 379 days after receiving the submission on June 19, 2007.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3070.
| 510(k) Number | K071668 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 19, 2007 |
| Decision Date | July 02, 2008 |
| Days to Decision | 379 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | MNI - Orthosis, Spinal Pedicle Fixation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3070 |