The following data is part of a premarket notification filed by Seaspine with the FDA for Ucr Spinal System.
| Device ID | K032739 |
| 510k Number | K032739 |
| Device Name: | UCR SPINAL SYSTEM |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | SEASPINE 727 PARK BLVD. San Diego, CA 92101 |
| Contact | Diana Smith |
| Correspondent | Diana Smith SEASPINE 727 PARK BLVD. San Diego, CA 92101 |
| Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-04 |
| Decision Date | 2003-11-20 |
| Summary: | summary |