The following data is part of a premarket notification filed by K2m, Inc. with the FDA for K2m Cocr Wire.
| Device ID | K103797 |
| 510k Number | K103797 |
| Device Name: | K2M COCR WIRE |
| Classification | Cerclage, Fixation |
| 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 | JDQ |
| CFR Regulation Number | 888.3010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-27 |
| Decision Date | 2011-05-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888857083844 | K103797 | 000 |
| 10888857083837 | K103797 | 000 |
| 10888857018143 | K103797 | 000 |