The following data is part of a premarket notification filed by Aap Implantate Ag with the FDA for Aap Cannulated Screw 2.0.
| Device ID | K130590 |
| 510k Number | K130590 |
| Device Name: | AAP CANNULATED SCREW 2.0 |
| Classification | Screw, 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 | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-07 |
| Decision Date | 2013-04-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04042409195259 | K130590 | 000 |
| 04042409195143 | K130590 | 000 |
| 04042409195129 | K130590 | 000 |
| 04042409195112 | K130590 | 000 |
| 04042409195105 | K130590 | 000 |
| 04042409195099 | K130590 | 000 |
| 04042409195082 | K130590 | 000 |
| 04042409195075 | K130590 | 000 |
| 04042409195068 | K130590 | 000 |
| 04042409195150 | K130590 | 000 |
| 04042409195167 | K130590 | 000 |
| 04042409195242 | K130590 | 000 |
| 04042409195235 | K130590 | 000 |
| 04042409195228 | K130590 | 000 |
| 04042409195211 | K130590 | 000 |
| 04042409195204 | K130590 | 000 |
| 04042409195198 | K130590 | 000 |
| 04042409195181 | K130590 | 000 |
| 04042409195174 | K130590 | 000 |
| 04042409195051 | K130590 | 000 |