Device Classification Name |
bone cement
|
510(k) Number |
K123081 |
Device Name |
BONOS R GENTA 1X20 MODEL 01-0228; BONOS R GENTA 2X20 MODEL 01-0229; BONOS R GENTA 1X40 MODEL 01-0217; BONOS R GENTA 2X40 |
Applicant |
AAP BIOMATERIALS GMBH & CO. KG |
LAGERSTRASSE 11-15 |
DIEBURG,
DE
64807
|
|
Applicant Contact |
VOLKER STIRNAL |
Correspondent |
AAP BIOMATERIALS GMBH & CO. KG |
LAGERSTRASSE 11-15 |
DIEBURG,
DE
64807
|
|
Correspondent Contact |
VOLKER STIRNAL |
Regulation Number | 888.3027
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 10/01/2012 |
Decision Date | 03/07/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
Yes
|
Recalls |
CDRH Recalls
|
|
|