Device Classification Name |
Posterior Cervical Screw System
|
510(k) Number |
K163375 |
Device Name |
INFINITY™ OCT System |
Applicant |
Medtronic Sofamor Danek USA, Inc. |
1800 Pyramid Place |
Memphis,
TN
38132
|
|
Applicant Contact |
Tejas Patel |
Correspondent |
Medtronic Sofamor Danek USA, Inc. |
1800 Pyramid Place |
Memphis,
TN
38132
|
|
Correspondent Contact |
Tejas Patel |
Regulation Number | 888.3075
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/01/2016 |
Decision Date | 08/21/2017 |
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
|
|
|