K101678 is an FDA 510(k) clearance for the ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM. This device is classified as a Orthosis, Spondylolisthesis Spinal Fixation (Class II - Special Controls, product code MNH).
Submitted by Spineart (Geneva, CH). The FDA issued a Cleared decision on July 28, 2010, 43 days after receiving the submission on June 15, 2010.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3070.
| 510(k) Number | K101678 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 15, 2010 |
| Decision Date | July 28, 2010 |
| Days to Decision | 43 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | MNH — Orthosis, Spondylolisthesis Spinal Fixation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3070 |