The following data is part of a premarket notification filed by K2m, Inc. with the FDA for Caspian Spinal System.
| Device ID | K101084 |
| 510k Number | K101084 |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-19 |
| Decision Date | 2010-10-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888857016095 | K101084 | 000 |
| 10888857015784 | K101084 | 000 |
| 10888857015777 | K101084 | 000 |
| 10888857015760 | K101084 | 000 |
| 10888857015753 | K101084 | 000 |
| 10888857015746 | K101084 | 000 |
| 10888857015739 | K101084 | 000 |
| 10888857015722 | K101084 | 000 |
| 10888857015715 | K101084 | 000 |
| 10888857015708 | K101084 | 000 |
| 10888857015692 | K101084 | 000 |
| 10888857015685 | K101084 | 000 |
| 10888857015678 | K101084 | 000 |
| 10888857015661 | K101084 | 000 |
| 10888857015791 | K101084 | 000 |
| 10888857015807 | K101084 | 000 |
| 10888857015814 | K101084 | 000 |
| 10888857016088 | K101084 | 000 |
| 10888857016057 | K101084 | 000 |
| 10888857016040 | K101084 | 000 |
| 10888857015937 | K101084 | 000 |
| 10888857015920 | K101084 | 000 |
| 10888857015913 | K101084 | 000 |
| 10888857015906 | K101084 | 000 |
| 10888857015890 | K101084 | 000 |
| 10888857015869 | K101084 | 000 |
| 10888857015852 | K101084 | 000 |
| 10888857015845 | K101084 | 000 |
| 10888857015838 | K101084 | 000 |
| 10888857015821 | K101084 | 000 |
| 10888857015654 | K101084 | 000 |