The following data is part of a premarket notification filed by K2m Inc. with the FDA for Everest Spinal System, Range (mesa And Denali) Spinal System, Caspian Oct (mesa Mini And Denali Mini) Spinal System, Yukon Oct Spinal System.
| Device ID | K181603 |
| 510k Number | K181603 |
| Device Name: | EVEREST Spinal System, RANGE (MESA And DENALI) Spinal System, CASPIAN OCT (MESA Mini And DENALI Mini) Spinal System, YUKON OCT Spinal System |
| Classification | Posterior Cervical Screw System |
| Applicant | K2M Inc. 600 Hope Pkwy. SE Leesburg, VA 20175 |
| Contact | Nancy Giezen |
| Correspondent | Karen E. Warden BackRoads Consulting, Inc PO Box 566 Chesterland, OH 44026 |
| Product Code | NKG |
| Subsequent Product Code | KWP |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | NKB |
| CFR Regulation Number | 888.3075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-19 |
| Decision Date | 2018-10-05 |
| Summary: | summary |