The following data is part of a premarket notification filed by K2m, Incorporated with the FDA for Caspian Oct/mesa Mini/denali Mini Spinal System.
| Device ID | K153370 |
| 510k Number | K153370 |
| Device Name: | Caspian OCT/MESA Mini/DENALI Mini Spinal System |
| Classification | Posterior Cervical Screw System |
| Applicant | K2M, Incorporated 751 Miller Drive SE Leesburg, VA 20175 |
| Contact | Nancy Giezen |
| Correspondent | Nancy Giezen K2M, Incorporated 751 Miller Drive Southeast 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 | 2015-11-23 |
| Decision Date | 2016-02-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888857271623 | K153370 | 000 |
| 10888857177581 | K153370 | 000 |
| 10888857177598 | K153370 | 000 |
| 10888857177604 | K153370 | 000 |
| 10888857177642 | K153370 | 000 |
| 10888857177659 | K153370 | 000 |
| 10888857177666 | K153370 | 000 |
| 10888857177673 | K153370 | 000 |
| 10888857177680 | K153370 | 000 |
| 10888857177697 | K153370 | 000 |
| 10888857177703 | K153370 | 000 |
| 10888857177710 | K153370 | 000 |
| 10888857177727 | K153370 | 000 |
| 10888857235847 | K153370 | 000 |
| 10888857235854 | K153370 | 000 |
| 10888857271593 | K153370 | 000 |
| 10888857271609 | K153370 | 000 |
| 10888857271616 | K153370 | 000 |
| 10888857014411 | K153370 | 000 |