The following data is part of a premarket notification filed by Depuy Spine, Inc. with the FDA for Mountaineer Laminoplasty System.
| Device ID | K091994 |
| 510k Number | K091994 |
| Device Name: | MOUNTAINEER LAMINOPLASTY SYSTEM |
| Classification | Orthosis, Spine, Plate, Laminoplasty, Metal |
| Applicant | DEPUY SPINE, INC. 325 PARAMOUNT DR. Raynham, MA 02767 |
| Contact | Daphney Germain |
| Correspondent | Daphney Germain DEPUY SPINE, INC. 325 PARAMOUNT DR. Raynham, MA 02767 |
| Product Code | NQW |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-02 |
| Decision Date | 2010-01-07 |
| Summary: | summary |