The following data is part of a premarket notification filed by Orthotec, L.l.c. with the FDA for Oria Spinal Clip System, Types Bd And Bj.
| Device ID | K023994 |
| 510k Number | K023994 |
| Device Name: | ORIA SPINAL CLIP SYSTEM, TYPES BD AND BJ |
| 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 |
| Subsequent Product Code | KWP |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-12-03 |
| Decision Date | 2003-02-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840996121163 | K023994 | 000 |
| 00840996121279 | K023994 | 000 |
| 00840996121286 | K023994 | 000 |
| 00840996121293 | K023994 | 000 |
| 00840996121309 | K023994 | 000 |
| 00840996121316 | K023994 | 000 |
| 00840996121323 | K023994 | 000 |
| 00840996121330 | K023994 | 000 |
| 00840996121347 | K023994 | 000 |
| 00840996121262 | K023994 | 000 |
| 00840996121255 | K023994 | 000 |
| 00840996121170 | K023994 | 000 |
| 00840996121187 | K023994 | 000 |
| 00840996121194 | K023994 | 000 |
| 00840996121200 | K023994 | 000 |
| 00840996121217 | K023994 | 000 |
| 00840996121224 | K023994 | 000 |
| 00840996121231 | K023994 | 000 |
| 00840996121248 | K023994 | 000 |
| 00840996121354 | K023994 | 000 |
| 00840996121361 | K023994 | 000 |
| 00840996121378 | K023994 | 000 |
| 00840996121484 | K023994 | 000 |
| 00840996121491 | K023994 | 000 |
| 00840996121507 | K023994 | 000 |
| 00840996121514 | K023994 | 000 |
| 00840996121521 | K023994 | 000 |
| 00840996121538 | K023994 | 000 |
| 00840996121545 | K023994 | 000 |
| 00840996121552 | K023994 | 000 |
| 00840996121477 | K023994 | 000 |
| 00840996121460 | K023994 | 000 |
| 00840996121385 | K023994 | 000 |
| 00840996121392 | K023994 | 000 |
| 00840996121408 | K023994 | 000 |
| 00840996121415 | K023994 | 000 |
| 00840996121422 | K023994 | 000 |
| 00840996121439 | K023994 | 000 |
| 00840996121446 | K023994 | 000 |
| 00840996121453 | K023994 | 000 |
| 00840996121569 | K023994 | 000 |