The following data is part of a premarket notification filed by Orthotec, L.l.c. with the FDA for Claris Plate System.
| Device ID | K010369 |
| 510k Number | K010369 |
| Device Name: | CLARIS PLATE SYSTEM |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | ORTHOTEC, L.L.C. 546 HILLGREEN DR. Beverly Hills, CA 90212 -4110 |
| Contact | Patrick Bertranou |
| Correspondent | Patrick Bertranou ORTHOTEC, L.L.C. 546 HILLGREEN DR. Beverly Hills, CA 90212 -4110 |
| Product Code | MNH |
| Subsequent Product Code | KWP |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-02-07 |
| Decision Date | 2001-05-08 |