Device Classification Name |
Appliance, Fixation, Spinal Intervertebral Body
|
510(k) Number |
K192494 |
Device Name |
NexGen Anterior Cervical Plate System |
Applicant |
Precision Spine |
2050 Executive Drive |
Pearl,
MS
39208
|
|
Applicant Contact |
Michael C. Dawson |
Correspondent |
The OrthoMedix Group, Inc. |
4313 W. 3800 S. |
West Haven,
UT
84401
|
|
Correspondent Contact |
J. D. Webb |
Regulation Number | 888.3060
|
Classification Product Code |
|
Date Received | 09/11/2019 |
Decision Date | 10/29/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|