The following data is part of a premarket notification filed by Aap Implantate Ag with the FDA for Aap Aps System.
Device ID | K071852 |
510k Number | K071852 |
Device Name: | AAP APS SYSTEM |
Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
Applicant | AAP IMPLANTATE AG LORENZWEG 5 Berlin, DE 12099 |
Contact | Marc Seegers |
Correspondent | Marc Seegers AAP IMPLANTATE AG LORENZWEG 5 Berlin, DE 12099 |
Product Code | KTT |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-07-05 |
Decision Date | 2007-08-29 |
Summary: | summary |