Device Classification Name |
Rod, Fixation, Intramedullary And Accessories
|
510(k) Number |
K201830 |
Device Name |
ANSER Clavicle Pin |
Applicant |
Baat Medical Products BV |
F. Hazemeijerstraat 800 - Building A04 |
RJ Hengelo,
NL
7555
|
|
Applicant Contact |
Teake Bulstra |
Correspondent |
Baat Medical Products BV |
F. Hazemeijerstraat 800 - Building A04 |
RJ Hengelo,
NL
7555
|
|
Correspondent Contact |
Teake Bulstra |
Regulation Number | 888.3020
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/02/2020 |
Decision Date | 08/27/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|