Device Classification Name |
posterior cervical screw system
|
510(k) Number |
K192354 |
Device Name |
Innovasis Gibralt Spine System |
Applicant |
Innovasis, Inc. |
614 East 3900 South |
Salt Lake City,
UT
84107
|
|
Applicant Contact |
Marshall McCarthy |
Correspondent |
Innovasis, Inc. |
614 East 3900 South |
Salt Lake City,
UT
84107
|
|
Correspondent Contact |
Marshall McCarthy |
Regulation Number | 888.3075
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/29/2019 |
Decision Date | 09/24/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|