Device Classification Name |
plate, bone
|
510(k) Number |
K230733 |
Device Name |
Stryker Resorbable Fixation System |
Applicant |
Stryker Leibinger GmbH & Co. KG |
Boetzinger Strasse 41 |
Freiburg,
DE
D-79111
|
|
Applicant Contact |
Gregory Gohl |
Correspondent |
Stryker Leibinger GmbH & Co. KG |
Boetzinger Strasse 41 |
Freiburg,
DE
D-79111
|
|
Correspondent Contact |
Gregory Gohl |
Regulation Number | 872.4760
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/16/2023 |
Decision Date | 08/05/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|