The following data is part of a premarket notification filed by Corin U.s.a. with the FDA for Rod To Rod Cross Braces.
| Device ID | K000634 |
| 510k Number | K000634 |
| Device Name: | ROD TO ROD CROSS BRACES |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | CORIN U.S.A. 10500 UNIVERSITY CENTER DR., SUITE 190 Tampa, FL 33612 |
| Contact | Joel Batts |
| Correspondent | Joel Batts CORIN U.S.A. 10500 UNIVERSITY CENTER DR., SUITE 190 Tampa, FL 33612 |
| Product Code | KWQ |
| Subsequent Product Code | KWP |
| Subsequent Product Code | MNH |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-25 |
| Decision Date | 2000-03-10 |