The following data is part of a premarket notification filed by Aap Implantate Ag with the FDA for Aap Cannulated Screw And Darco Headed Screw.
| Device ID | K080101 |
| 510k Number | K080101 |
| Device Name: | AAP CANNULATED SCREW AND DARCO HEADED SCREW |
| Classification | Screw, Fixation, Bone |
| 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 | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-01-14 |
| Decision Date | 2008-03-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04042409185649 | K080101 | 000 |
| 04042409185656 | K080101 | 000 |