The following data is part of a premarket notification filed by Aap Implantate Ag with the FDA for Loqteq Proximal Humerus Plate 3.5 System.
| Device ID | K211582 |
| 510k Number | K211582 |
| Device Name: | LOQTEQ Proximal Humerus Plate 3.5 System |
| Classification | Plate, Fixation, Bone |
| Applicant | aap Implantate AG Lorenzweg 5 Berlin, DE 12099 |
| Contact | Agnieszka Mierzejewska |
| Correspondent | Melissa Burbage PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, CA 92130 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-21 |
| Decision Date | 2021-10-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04042409256707 | K211582 | 000 |
| 04042409233944 | K211582 | 000 |