The following data is part of a premarket notification filed by Seaspine, Inc. with the FDA for Sierra System.
| Device ID | K080526 |
| 510k Number | K080526 |
| Device Name: | SIERRA SYSTEM |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | SEASPINE, INC. 2302 LA MIRADA DR. Vista, CA 92081 -7862 |
| Contact | Ethel Bernal |
| Correspondent | Ethel Bernal SEASPINE, INC. 2302 LA MIRADA DR. Vista, CA 92081 -7862 |
| Product Code | KWP |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-26 |
| Decision Date | 2008-04-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10889981057640 | K080526 | 000 |
| 10889981057633 | K080526 | 000 |
| 10889981057626 | K080526 | 000 |
| 10889981057619 | K080526 | 000 |
| 10889981057602 | K080526 | 000 |