The following data is part of a premarket notification filed by Qualgenix Llc with the FDA for Blue Mountain Cervical Plate.
| Device ID | K112809 |
| 510k Number | K112809 |
| Device Name: | BLUE MOUNTAIN CERVICAL PLATE |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | QUALGENIX LLC 1 JACK'S HILL ROAD UNIT 3E Oxford, CT 06478 |
| Contact | Richard Deslauriers |
| Correspondent | Richard Deslauriers QUALGENIX LLC 1 JACK'S HILL ROAD UNIT 3E Oxford, CT 06478 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-27 |
| Decision Date | 2012-06-20 |
| Summary: | summary |