Device Classification Name |
Appliance, Fixation, Spinal Intervertebral Body
|
510(k) Number |
K122216 |
Device Name |
RELIANCE ANTERIOR CERVICAL PLATE SYSTEM |
Applicant |
Reliance Medical Systems, LLC |
545 SOUTH 500 WEST |
SUITE 100 |
BOUNTIFUL,
UT
84010
|
|
Applicant Contact |
Bret M Berry |
Correspondent |
Reliance Medical Systems, LLC |
545 SOUTH 500 WEST |
SUITE 100 |
BOUNTIFUL,
UT
84010
|
|
Correspondent Contact |
Bret M Berry |
Regulation Number | 888.3060
|
Classification Product Code |
|
Date Received | 07/25/2012 |
Decision Date | 09/05/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|