Device Classification Name |
plate, fixation, bone
|
510(k) Number |
K113652 |
Device Name |
LOQTEQ SMALL FRAGMENT SET LOQTEQ CORTICAL SCREW3.5, SMALL HEAD, T15, SELF TAPPING LOQTEQ CORTICAL SCREW 3.5, T15, SELF T |
Applicant |
AAP IMPLANTATE AG |
LORENZWEG 5 |
BERLIN,
DE
12099
|
|
Applicant Contact |
MARC SEEGERS |
Correspondent |
AAP IMPLANTATE AG |
LORENZWEG 5 |
BERLIN,
DE
12099
|
|
Correspondent Contact |
MARC SEEGERS |
Regulation Number | 888.3030
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/12/2011 |
Decision Date | 08/30/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|