The following data is part of a premarket notification filed by Spine View, Inc. with the FDA for Spineview X-pac Expandable Lumbar Cage System.
| Device ID | K152539 |
| 510k Number | K152539 |
| Device Name: | SpineView X-Pac Expandable Lumbar Cage System |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | SPINE VIEW, INC. 48810 KATO ROAD SUITE 100E Fremont, CA 94538 |
| Contact | Mbithi Muthini |
| Correspondent | Sevrina Ciucci Lince Consulting 8 Crow Canyon Court #205 San Ramon, CA 94583 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-04 |
| Decision Date | 2016-02-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00853954003340 | K152539 | 000 |
| 00853954003210 | K152539 | 000 |
| 00853954003227 | K152539 | 000 |
| 00853954003234 | K152539 | 000 |
| 00853954003241 | K152539 | 000 |
| 00853954003258 | K152539 | 000 |
| 00853954003265 | K152539 | 000 |
| 00853954003272 | K152539 | 000 |
| 00853954003289 | K152539 | 000 |
| 00853954003296 | K152539 | 000 |
| 00853954003302 | K152539 | 000 |
| 00853954003319 | K152539 | 000 |
| 00853954003326 | K152539 | 000 |
| 00853954003333 | K152539 | 000 |
| 00853954003180 | K152539 | 000 |