The following data is part of a premarket notification filed by K2m Inc. with the FDA for Pyrenees Cervical Plate System, Blue Ridge Cervical Plate System, Ozark Cervical Plate System, Cayman Thoracolumbar And Buttress Plate Systems.
| Device ID | K182473 |
| 510k Number | K182473 |
| Device Name: | PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate System, CAYMAN Thoracolumbar And Buttress Plate Systems |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | K2M Inc. 600 Hope Pkwy. SE Leesburg, VA 20175 |
| Contact | Nancy Giezen |
| Correspondent | Karen E. Warden, Ph.d. BackRoads Consulting, Inc PO Box 566 Chesterland, OH 44026 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-10 |
| Decision Date | 2018-12-12 |
| Summary: | summary |