The following data is part of a premarket notification filed by Aap Implantate Ag with the FDA for Loqteq Distal Lateral Femur Plate 4.5 System.
| Device ID | K210043 |
| 510k Number | K210043 |
| Device Name: | LOQTEQ Distal Lateral Femur Plate 4.5 System |
| Classification | Plate, Fixation, Bone |
| Applicant | AAP Implantate AG Lorenzweg 5 Berlin, DE 12099 |
| Contact | Agnieszka Mierzejewska |
| Correspondent | Kevin A. Thomas 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 | 2021-01-07 |
| Decision Date | 2021-03-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04042409393242 | K210043 | 000 |
| 04042409393235 | K210043 | 000 |
| 04042409393228 | K210043 | 000 |
| 04042409393211 | K210043 | 000 |