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 |