The following data is part of a premarket notification filed by Aap Implantate Ag with the FDA for Aap Cannulated Screw, 7.5mm, 4.5mm, 4.0mm, 3.5mm, 7.0mm.
| Device ID | K990776 |
| 510k Number | K990776 |
| Device Name: | AAP CANNULATED SCREW, 7.5MM, 4.5MM, 4.0MM, 3.5MM, 7.0MM |
| Classification | Screw, Fixation, Bone |
| Applicant | AAP IMPLANTATE AG 73 EAGLES NEST RD. Duxbury, MA 02332 |
| Contact | Ellen Henke-knupp |
| Correspondent | Ellen Henke-knupp AAP IMPLANTATE AG 73 EAGLES NEST RD. Duxbury, MA 02332 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-09 |
| Decision Date | 1999-04-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EATO430490SINGLE9 | K990776 | 000 |
| 04042409088520 | K990776 | 000 |
| 04042409088506 | K990776 | 000 |
| 04042409088483 | K990776 | 000 |
| 04042409088452 | K990776 | 000 |
| 04042409088438 | K990776 | 000 |
| 04042409088407 | K990776 | 000 |
| 04042409088384 | K990776 | 000 |
| 04042409382550 | K990776 | 000 |