The following data is part of a premarket notification filed by K2m, Inc. with the FDA for K2m Modular Hooks.
Device ID | K133402 |
510k Number | K133402 |
Device Name: | K2M MODULAR HOOKS |
Classification | Thoracolumbosacral Pedicle Screw System |
Applicant | K2M, INC. PO BOX 566 Chesterland, OH 44026 -2141 |
Contact | Karen E Warden |
Correspondent | Karen E Warden K2M, INC. PO BOX 566 Chesterland, OH 44026 -2141 |
Product Code | NKB |
Subsequent Product Code | KWP |
Subsequent Product Code | KWQ |
Subsequent Product Code | MNH |
Subsequent Product Code | MNI |
Subsequent Product Code | OSH |
CFR Regulation Number | 888.3070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-11-06 |
Decision Date | 2014-07-30 |
Summary: | summary |