The following data is part of a premarket notification filed by K2m, Inc. with the FDA for K2m Patient Specific Rods.
Device ID | K180376 |
510k Number | K180376 |
Device Name: | K2M Patient Specific Rods |
Classification | Thoracolumbosacral Pedicle Screw System |
Applicant | K2M, Inc. 600 Hope Parkway SE Leesburg, VA 20175 |
Contact | Nancy Giezen |
Correspondent | Nancy Giezen K2M, Inc. 600 Hope Parkway Southeast Leesburg, VA 20175 |
Product Code | NKB |
Subsequent Product Code | KWP |
Subsequent Product Code | KWQ |
CFR Regulation Number | 888.3070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-02-12 |
Decision Date | 2018-04-05 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10888857413054 | K180376 | 000 |
10888857413047 | K180376 | 000 |
10888857413030 | K180376 | 000 |
10888857413023 | K180376 | 000 |
10888857548701 | K180376 | 000 |
10888857548695 | K180376 | 000 |