The following data is part of a premarket notification filed by K2m, Llc with the FDA for Mesa Spinal System.
| Device ID | K052398 |
| 510k Number | K052398 |
| Device Name: | MESA SPINAL SYSTEM |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | K2M, LLC 751 MILLER DR.,S.E., SUITE F1 Leesburg, VA 20175 |
| Contact | Richard W Woods |
| Correspondent | Richard W Woods K2M, LLC 751 MILLER DR.,S.E., SUITE F1 Leesburg, VA 20175 |
| Product Code | MNI |
| Subsequent Product Code | KWP |
| Subsequent Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-31 |
| Decision Date | 2005-12-07 |
| Summary: | summary |