The following data is part of a premarket notification filed by K2m, Inc. with the FDA for Pyrenees Cervical Plate System, Semi-constrained Screws.
| Device ID | K092474 |
| 510k Number | K092474 |
| Device Name: | PYRENEES CERVICAL PLATE SYSTEM, SEMI-CONSTRAINED SCREWS |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | K2M, INC. 751 MILLER DR.,SE Leesburg, VA 20175 |
| Contact | Richard W Woods |
| Correspondent | Richard W Woods K2M, INC. 751 MILLER DR.,SE Leesburg, VA 20175 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-12 |
| Decision Date | 2010-03-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888857026865 | K092474 | 000 |
| 10888857026643 | K092474 | 000 |
| 10888857026650 | K092474 | 000 |
| 10888857026667 | K092474 | 000 |
| 10888857026674 | K092474 | 000 |
| 10888857026681 | K092474 | 000 |
| 10888857026698 | K092474 | 000 |
| 10888857026704 | K092474 | 000 |
| 10888857026766 | K092474 | 000 |
| 10888857026773 | K092474 | 000 |
| 10888857026780 | K092474 | 000 |
| 10888857026797 | K092474 | 000 |
| 10888857026827 | K092474 | 000 |
| 10888857026834 | K092474 | 000 |
| 10888857026841 | K092474 | 000 |
| 10888857026858 | K092474 | 000 |
| 10888857026636 | K092474 | 000 |