| Device Classification Name |
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
|
| 510(k) Number |
K071852 |
| Device Name |
AAP APS SYSTEM |
| 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 |
|
| Date Received | 07/05/2007 |
| Decision Date | 08/29/2007 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Orthopedic
|
| 510k Review Panel |
Orthopedic
|
| Summary |
Summary
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|