The following data is part of a premarket notification filed by Seaspine, Inc. with the FDA for Integra Laminoplasty System.
| Device ID | K150469 |
| 510k Number | K150469 |
| Device Name: | Integra Laminoplasty System |
| Classification | Orthosis, Spine, Plate, Laminoplasty, Metal |
| Applicant | SEASPINE, INC. 2302 LA MIRADA DRIVE Vista, CA 92081 |
| Contact | Michelle Willis |
| Correspondent | Michelle Willis SEASPINE, INC. 2302 LA MIRADA DRIVE Vista, CA 92081 |
| Product Code | NQW |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-23 |
| Decision Date | 2015-03-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10889981076047 | K150469 | 000 |
| 10889981075781 | K150469 | 000 |
| 10889981075804 | K150469 | 000 |
| 10889981075828 | K150469 | 000 |
| 10889981075873 | K150469 | 000 |
| 10889981075897 | K150469 | 000 |
| 10889981075910 | K150469 | 000 |
| 10889981075934 | K150469 | 000 |
| 10889981075989 | K150469 | 000 |
| 10889981076009 | K150469 | 000 |
| 10889981076023 | K150469 | 000 |
| 10889981075767 | K150469 | 000 |