Device Classification Name |
bone cement
|
510(k) Number |
K210125 |
Device Name |
BonOs HV Genta, BonOs MV Genta, BonOs LV Genta |
Applicant |
OSARTIS GmbH |
Auf der Beune 101 |
Munster,
DE
64839
|
|
Applicant Contact |
Volker Stirnal |
Correspondent |
OSARTIS GmbH |
Auf der Beune 101 |
Munster,
DE
64839
|
|
Correspondent Contact |
Volker Stirnal |
Regulation Number | 888.3027
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 01/19/2021 |
Decision Date | 03/19/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
Yes
|
|
|