The following data is part of a premarket notification filed by K2m, Inc. with the FDA for Nile Alternative Fixation.
Device ID | K143350 |
510k Number | K143350 |
Device Name: | Nile Alternative Fixation |
Classification | Bone Fixation Cerclage, Sublaminar |
Applicant | K2M, Inc. 751 Miller Drive SE Leesburg, VA 20175 |
Contact | Nancy Giezen |
Correspondent | Nancy Giezen K2M, Inc. 751 Miller Drive SE Leesburg, VA 20175 |
Product Code | OWI |
CFR Regulation Number | 888.3010 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-11-24 |
Decision Date | 2015-02-25 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10888857157699 | K143350 | 000 |
10888857157682 | K143350 | 000 |
10888857156371 | K143350 | 000 |
10888857156364 | K143350 | 000 |
10888857111608 | K143350 | 000 |
10888857111592 | K143350 | 000 |
10888857047716 | K143350 | 000 |
10888857000025 | K143350 | 000 |
10888857000018 | K143350 | 000 |