Device Classification Name |
appliance, fixation, spinal intervertebral body
|
510(k) Number |
K192049 |
Device Name |
Oryx Cervical Plate System |
Applicant |
Innovasis, Inc. |
614 East 3900 South |
Salt Lake City,
UT
84107
|
|
Applicant Contact |
Marshall McCarty |
Correspondent |
Innovasis, Inc. |
614 East 3900 South |
Salt Lake City,
UT
84107
|
|
Correspondent Contact |
Marshall McCarty |
Regulation Number | 888.3060
|
Classification Product Code |
|
Date Received | 07/31/2019 |
Decision Date | 11/08/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|