The following data is part of a premarket notification filed by Aap Implantate Ag with the FDA for Aap Acroplate.
| Device ID | K030909 |
| 510k Number | K030909 |
| Device Name: | AAP ACROPLATE |
| Classification | Plate, Fixation, Bone |
| Applicant | AAP IMPLANTATE AG LORENZWEG 5 Berlin, DE 12099 |
| Contact | Dipl.-lng. Christian Abel |
| Correspondent | Dipl.-lng. Christian Abel AAP IMPLANTATE AG LORENZWEG 5 Berlin, DE 12099 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-24 |
| Decision Date | 2003-04-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04042409102516 | K030909 | 000 |
| 04042409102509 | K030909 | 000 |
| 04042409098567 | K030909 | 000 |
| 04042409098550 | K030909 | 000 |
| 04042409072741 | K030909 | 000 |
| 04042409072734 | K030909 | 000 |
| 04042409072727 | K030909 | 000 |
| 04042409072710 | K030909 | 000 |