The following data is part of a premarket notification filed by Aap Implantate Ag with the FDA for Aap Loqteq® Distal Lateral Humerus Plate 2.7/3.5.
| Device ID | K161696 |
| 510k Number | K161696 |
| Device Name: | Aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5 |
| Classification | Plate, Fixation, Bone |
| Applicant | AAP IMPLANTATE AG LORENZWEG 5 Berlin, DE 12099 |
| Contact | Reni Schaller |
| Correspondent | Reni Schaller 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 | 2016-06-20 |
| Decision Date | 2016-11-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04042409360534 | K161696 | 000 |
| 04042409360459 | K161696 | 000 |
| 04042409360466 | K161696 | 000 |
| 04042409360473 | K161696 | 000 |
| 04042409360480 | K161696 | 000 |
| 04042409360497 | K161696 | 000 |
| 04042409360503 | K161696 | 000 |
| 04042409360510 | K161696 | 000 |
| 04042409360527 | K161696 | 000 |
| 04042409360442 | K161696 | 000 |