The following data is part of a premarket notification filed by K2m with the FDA for Yukon Oct Spinal System.
| Device ID | K182182 |
| 510k Number | K182182 |
| Device Name: | YUKON OCT Spinal System |
| Classification | Posterior Cervical Screw System |
| Applicant | K2M 600 Hope Parkway SE Leesburg, VA 20175 |
| Contact | Nancy Giezen |
| Correspondent | Nancy Giezen K2M 600 Hope Parkway SE Leesburg, VA 20175 |
| Product Code | NKG |
| CFR Regulation Number | 888.3075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-13 |
| Decision Date | 2018-11-15 |
| Summary: | summary |