The following data is part of a premarket notification filed by Aap Implantate Ag with the FDA for Aap Loqtec(r) Olecranon Plate.
| Device ID | K140607 |
| 510k Number | K140607 |
| Device Name: | AAP LOQTEC(R) OLECRANON PLATE |
| Classification | Plate, 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 | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-10 |
| Decision Date | 2014-05-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04042409283857 | K140607 | 000 |
| 04042409283741 | K140607 | 000 |
| 04042409283758 | K140607 | 000 |
| 04042409283772 | K140607 | 000 |
| 04042409283796 | K140607 | 000 |
| 04042409283819 | K140607 | 000 |
| 04042409283826 | K140607 | 000 |
| 04042409283833 | K140607 | 000 |
| 04042409283840 | K140607 | 000 |
| 04042409283703 | K140607 | 000 |