The following data is part of a premarket notification filed by K2m, Inc with the FDA for Range/denali/mesa Spinal System.
Device ID | K143334 |
510k Number | K143334 |
Device Name: | Range/Denali/Mesa Spinal System |
Classification | Thoracolumbosacral Pedicle Screw System |
Applicant | K2M, INC 571 MILLER DRIVE SE Leesburg, VA 20175 |
Contact | Nancy Giezen |
Correspondent | Nancy Giezen K2M, INC 751 MILLER DRIVE SE Leesburg, VA 20175 |
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 | 2014-11-20 |
Decision Date | 2015-01-09 |
Summary: | summary |