The following data is part of a premarket notification filed by Depuy Spine, Inc. with the FDA for Mountaineer Oct Spinal System.
| Device ID | K080828 |
| 510k Number | K080828 |
| Device Name: | MOUNTAINEER OCT SPINAL SYSTEM |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | DEPUY SPINE, INC. 325 PARAMOUNT DR. Raynham, MA 02767 |
| Contact | Lisa Gilman |
| Correspondent | Lisa Gilman DEPUY SPINE, INC. 325 PARAMOUNT DR. Raynham, MA 02767 |
| Product Code | MNH |
| Subsequent Product Code | KWP |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-25 |
| Decision Date | 2008-06-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10705034158587 | K080828 | 000 |
| 10705034158570 | K080828 | 000 |
| 10705034158563 | K080828 | 000 |
| 10705034158556 | K080828 | 000 |
| 10705034158549 | K080828 | 000 |
| 10705034158532 | K080828 | 000 |