The following data is part of a premarket notification filed by K2m, Inc. with the FDA for Caspian Spinal System.
| Device ID | K141284 |
| 510k Number | K141284 |
| Device Name: | CASPIAN SPINAL SYSTEM |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | K2M, INC. 751 MILLER DR.,SE Leesburg, VA 20175 |
| Contact | Nancy Giezen |
| Correspondent | Nancy Giezen K2M, INC. 751 MILLER DR.,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 | 2014-05-16 |
| Decision Date | 2014-07-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888857153837 | K141284 | 000 |
| 10888857153820 | K141284 | 000 |
| 10888857153813 | K141284 | 000 |