The following data is part of a premarket notification filed by Orthotec, L.l.c. with the FDA for Oria Claris.
| Device ID | K023378 |
| 510k Number | K023378 |
| Device Name: | ORIA CLARIS |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | ORTHOTEC, L.L.C. 9595 WILSHIRE BLVD. SUITE 502 Beverly Hills, CA 90212 |
| Contact | Patrick Bertranou |
| Correspondent | Patrick Bertranou ORTHOTEC, L.L.C. 9595 WILSHIRE BLVD. SUITE 502 Beverly Hills, CA 90212 |
| Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-08 |
| Decision Date | 2003-06-27 |
| Summary: | summary |