K000634 is an FDA 510(k) clearance for the ROD TO ROD CROSS BRACES. This device is classified as a Appliance, Fixation, Spinal Intervertebral Body (Class II - Special Controls, product code KWQ).
Submitted by Corin USA (Tampa, US). The FDA issued a Cleared decision on March 10, 2000, 14 days after receiving the submission on February 25, 2000.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3060.
| 510(k) Number | K000634 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 25, 2000 |
| Decision Date | March 10, 2000 |
| Days to Decision | 14 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Statement |
| Product Code | KWQ - Appliance, Fixation, Spinal Intervertebral Body |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3060 |