The following data is part of a premarket notification filed by K2m, Inc. with the FDA for Yukon Oct Spinal System.
| Device ID | K193129 |
| 510k Number | K193129 |
| Device Name: | Yukon OCT Spinal System |
| Classification | Posterior Cervical Screw System |
| Applicant | K2M, Inc. 600 Hope Parkway SE Leesburg, VA 20175 |
| Contact | Oonagh Lahiff |
| Correspondent | Ali Khan Stryker 59 Route 17 Allendale, NJ 07401 |
| Product Code | NKG |
| CFR Regulation Number | 888.3075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-12 |
| Decision Date | 2020-02-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888857468276 | K193129 | 000 |
| 10888857464032 | K193129 | 000 |
| 10888857464049 | K193129 | 000 |
| 10888857464056 | K193129 | 000 |
| 10888857464063 | K193129 | 000 |
| 10888857464070 | K193129 | 000 |
| 10888857464087 | K193129 | 000 |
| 10888857464094 | K193129 | 000 |
| 10888857464100 | K193129 | 000 |
| 10888857464117 | K193129 | 000 |
| 10888857464124 | K193129 | 000 |
| 10888857464131 | K193129 | 000 |
| 10888857468177 | K193129 | 000 |
| 10888857468184 | K193129 | 000 |
| 10888857468191 | K193129 | 000 |
| 10888857468207 | K193129 | 000 |
| 10888857468214 | K193129 | 000 |
| 10888857468221 | K193129 | 000 |
| 10888857464025 | K193129 | 000 |