The following data is part of a premarket notification filed by Seaspine with the FDA for Ucr Spinal System, Laminar Hooks, Pedicle Hooks, And Instruments.
| Device ID | K031381 |
| 510k Number | K031381 |
| Device Name: | UCR SPINAL SYSTEM, LAMINAR HOOKS, PEDICLE HOOKS, AND INSTRUMENTS |
| 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 |
| Subsequent Product Code | KWP |
| Subsequent Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-01 |
| Decision Date | 2003-07-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10889981036201 | K031381 | 000 |
| 10889981036195 | K031381 | 000 |
| 10889981036188 | K031381 | 000 |
| 10889981003029 | K031381 | 000 |
| 10889981003012 | K031381 | 000 |