The following data is part of a premarket notification filed by Depuy Spine, Inc. with the FDA for Mountaineer Oct Spinal System.
| Device ID | K110353 |
| 510k Number | K110353 |
| Device Name: | MOUNTAINEER OCT SPINAL SYSTEM |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | DEPUY SPINE, INC. 325 PARAMOUNT DR. Raynham, MA 02767 |
| Contact | Luke Bulino |
| Correspondent | Luke Bulino DEPUY SPINE, INC. 325 PARAMOUNT DR. Raynham, MA 02767 |
| Product Code | KWP |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-02-07 |
| Decision Date | 2011-04-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10705034466392 | K110353 | 000 |
| 10705034290416 | K110353 | 000 |
| 10705034290409 | K110353 | 000 |
| 10705034290393 | K110353 | 000 |
| 10705034290386 | K110353 | 000 |
| 10705034290379 | K110353 | 000 |
| 10705034290362 | K110353 | 000 |
| 10705034290355 | K110353 | 000 |
| 10705034290348 | K110353 | 000 |
| 10705034290331 | K110353 | 000 |
| 10705034290324 | K110353 | 000 |
| 10705034290317 | K110353 | 000 |
| 10705034290300 | K110353 | 000 |
| 10705034290294 | K110353 | 000 |
| 10705034290423 | K110353 | 000 |
| 10705034290430 | K110353 | 000 |
| 10705034290560 | K110353 | 000 |
| 10705034290553 | K110353 | 000 |
| 10705034290546 | K110353 | 000 |
| 10705034290539 | K110353 | 000 |
| 10705034290522 | K110353 | 000 |
| 10705034290515 | K110353 | 000 |
| 10705034290508 | K110353 | 000 |
| 10705034290492 | K110353 | 000 |
| 10705034290485 | K110353 | 000 |
| 10705034290478 | K110353 | 000 |
| 10705034290461 | K110353 | 000 |
| 10705034290454 | K110353 | 000 |
| 10705034290447 | K110353 | 000 |
| 10705034290287 | K110353 | 000 |