The following data is part of a premarket notification filed by Seaspine with the FDA for Anterior Lumbar Buttress System.
| Device ID | K040130 |
| 510k Number | K040130 |
| Device Name: | ANTERIOR LUMBAR BUTTRESS SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| 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 | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-01-21 |
| Decision Date | 2004-03-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10889981051846 | K040130 | 000 |
| 10889981051839 | K040130 | 000 |
| 10889981051822 | K040130 | 000 |
| 10889981051815 | K040130 | 000 |
| 10889981051808 | K040130 | 000 |
| 10889981051792 | K040130 | 000 |
| 10889981051785 | K040130 | 000 |
| 10889981051778 | K040130 | 000 |