The following data is part of a premarket notification filed by Aap Implantate Ag with the FDA for Aap K-wire, Steinmann Pin, Cerclage Wire.
Device ID | K131459 |
510k Number | K131459 |
Device Name: | AAP K-WIRE, STEINMANN PIN, CERCLAGE WIRE |
Classification | Pin, Fixation, Threaded |
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 | JDW |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-05-20 |
Decision Date | 2013-10-17 |
Summary: | summary |