Device Classification Name |
intervertebral fusion device with bone graft, cervical
|
510(k) Number |
K172489 |
Device Name |
Reliance Cervical IBF System |
Applicant |
Reliance Medical Systems, LLC |
545 West 500 South, Suite 100 |
Bountiful,
UT
84010
|
|
Applicant Contact |
Bret M. Berry |
Correspondent |
Reliance Medical Systems, LLC |
545 West 500 South, Suite 100 |
Bountiful,
UT
84010
|
|
Correspondent Contact |
Bret M. Berry |
Regulation Number | 888.3080
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/17/2017 |
Decision Date | 09/07/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|