Device Classification Name |
Thoracolumbosacral Pedicle Screw System
|
510(k) Number |
K141873 |
Device Name |
RANGE/MESA/DENALI SPINAL SYSTEM |
Applicant |
K2M, INC. |
751 MILLER DR SE |
LEESBURG,
VA
22066
|
|
Applicant Contact |
NANCY GLEZEN |
Correspondent |
K2M, INC. |
751 MILLER DR SE |
LEESBURG,
VA
22066
|
|
Correspondent Contact |
NANCY GLEZEN |
Regulation Number | 888.3070
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 07/11/2014 |
Decision Date | 09/08/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|