The following data is part of a premarket notification filed by K2m with the FDA for Caspian Oct/mesa Mini/denali Mini Spinal System.
| Device ID | K142558 |
| 510k Number | K142558 |
| Device Name: | Caspian OCT/MESA Mini/DENALI Mini Spinal System |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | K2M 751 Miller Drive SE Leesburg, VA 20175 |
| Contact | Nancy Giezen |
| Correspondent | Nancy Giezen K2M 751 Miller Drive SE Leesburg, VA 20175 |
| Product Code | KWP |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-11 |
| Decision Date | 2014-12-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888857158054 | K142558 | 000 |
| 10888857157873 | K142558 | 000 |
| 10888857157866 | K142558 | 000 |
| 10888857157859 | K142558 | 000 |
| 10888857157842 | K142558 | 000 |
| 10888857157835 | K142558 | 000 |
| 10888857157828 | K142558 | 000 |
| 10888857157811 | K142558 | 000 |
| 10888857157804 | K142558 | 000 |
| 10888857017979 | K142558 | 000 |
| 10888857017962 | K142558 | 000 |
| 10888857017948 | K142558 | 000 |
| 10888857016118 | K142558 | 000 |
| 10888857016101 | K142558 | 000 |
| 10888857016071 | K142558 | 000 |
| 10888857157880 | K142558 | 000 |
| 10888857157897 | K142558 | 000 |
| 10888857157903 | K142558 | 000 |
| 10888857158047 | K142558 | 000 |
| 10888857158030 | K142558 | 000 |
| 10888857158023 | K142558 | 000 |
| 10888857158016 | K142558 | 000 |
| 10888857158009 | K142558 | 000 |
| 10888857157996 | K142558 | 000 |
| 10888857157989 | K142558 | 000 |
| 10888857157972 | K142558 | 000 |
| 10888857157965 | K142558 | 000 |
| 10888857157958 | K142558 | 000 |
| 10888857157941 | K142558 | 000 |
| 10888857157934 | K142558 | 000 |
| 10888857157927 | K142558 | 000 |
| 10888857157910 | K142558 | 000 |
| 10888857016064 | K142558 | 000 |