Device Classification Name |
Screw, Fixation, Bone
|
510(k) Number |
K213199 |
Device Name |
Asnis® III Cannulated Screw System and Asnis® PRO Cannulated Screw System |
Applicant |
Stryker GmbH |
325 Corporate Drive |
Mahwah,
NJ
07430
|
|
Applicant Contact |
Danielle Jannuzzi Madureira |
Correspondent |
Stryker GmbH |
325 Corporate Drive |
Mahwah,
NJ
07430
|
|
Correspondent Contact |
Danielle Jannuzzi Madureira |
Regulation Number | 888.3040 |
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/29/2021 |
Decision Date | 01/11/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|