The following data is part of a premarket notification filed by Depuy Spine, Inc. with the FDA for Mountaineer Oct Spinal System.
| Device ID | K103100 |
| 510k Number | K103100 |
| Device Name: | MOUNTAINEER OCT SPINAL SYSTEM |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | DEPUY SPINE, INC. 325 PARAMOUNT DR. Raynham, MA 02767 |
| Contact | Eugene Bang |
| Correspondent | Eugene Bang DEPUY SPINE, INC. 325 PARAMOUNT DR. Raynham, MA 02767 |
| Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-20 |
| Decision Date | 2010-11-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10705034158525 | K103100 | 000 |
| 10705034158389 | K103100 | 000 |
| 10705034158396 | K103100 | 000 |
| 10705034158402 | K103100 | 000 |
| 10705034158419 | K103100 | 000 |
| 10705034158426 | K103100 | 000 |
| 10705034158433 | K103100 | 000 |
| 10705034158440 | K103100 | 000 |
| 10705034158457 | K103100 | 000 |
| 10705034158464 | K103100 | 000 |
| 10705034158471 | K103100 | 000 |
| 10705034158488 | K103100 | 000 |
| 10705034158495 | K103100 | 000 |
| 10705034158501 | K103100 | 000 |
| 10705034158518 | K103100 | 000 |
| 10705034158372 | K103100 | 000 |