The following data is part of a premarket notification filed by Aap Implantate Ag with the FDA for Aap Radius Set 2.5.
Device ID | K123875 |
510k Number | K123875 |
Device Name: | AAP RADIUS SET 2.5 |
Classification | Plate, Fixation, Bone |
Applicant | AAP IMPLANTATE AG LORENZWEG 5 Berlin, DE 12099 |
Contact | Christian Zietsch |
Correspondent | Christian Zietsch AAP IMPLANTATE AG LORENZWEG 5 Berlin, DE 12099 |
Product Code | HRS |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-12-17 |
Decision Date | 2013-03-11 |
Summary: | summary |