Device Classification Name |
Rod, Fixation, Intramedullary And Accessories
|
510(k) Number |
K181026 |
Device Name |
OsteoBridge™ IDSF System |
Applicant |
Merete GmbH |
Alt-Lankwitz 102 |
Berlin,
DE
12247
|
|
Applicant Contact |
Paul Munch |
Correspondent |
Merete GmbH |
Alt-Lankwitz 102 |
Berlin,
DE
12247
|
|
Correspondent Contact |
Paul Munch |
Regulation Number | 888.3020
|
Classification Product Code |
|
Date Received | 04/18/2018 |
Decision Date | 10/17/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|