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 |