The following data is part of a premarket notification filed by Orthotec, L.l.c. with the FDA for Oria Spinal Clip System Extended Omniaxial Connectors (co05 & Co07).
| Device ID | K030252 |
| 510k Number | K030252 |
| Device Name: | ORIA SPINAL CLIP SYSTEM EXTENDED OMNIAXIAL CONNECTORS (CO05 & CO07) |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| 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 | KWP |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-01-24 |
| Decision Date | 2003-02-21 |
| Summary: | summary |