The following data is part of a premarket notification filed by Aap Implantate Ag with the FDA for Loqteq Va Calcaneus Plate 3.5.
| Device ID | K182818 |
| 510k Number | K182818 |
| Device Name: | LOQTEQ VA Calcaneus Plate 3.5 |
| Classification | Plate, Fixation, Bone |
| Applicant | aap Implantate AG Lorenzweg 5 Berlin, DE D-12099 |
| Contact | Annesha Lahiri |
| Correspondent | Annesha Lahiri aap Implantate AG Lorenzweg 5 Berlin, DE D-12099 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-10-03 |
| Decision Date | 2019-08-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04042409398230 | K182818 | 000 |
| 04042409398056 | K182818 | 000 |
| 04042409398049 | K182818 | 000 |
| 04042409398032 | K182818 | 000 |
| 04042409398025 | K182818 | 000 |
| 04042409398018 | K182818 | 000 |
| 04042409398001 | K182818 | 000 |
| 04042409397998 | K182818 | 000 |
| 04042409397981 | K182818 | 000 |
| 04042409385605 | K182818 | 000 |
| 04042409385599 | K182818 | 000 |
| 04042409385582 | K182818 | 000 |
| 04042409385575 | K182818 | 000 |
| 04042409385520 | K182818 | 000 |
| 04042409385513 | K182818 | 000 |
| 04042409385506 | K182818 | 000 |
| 04042409398063 | K182818 | 000 |
| 04042409398070 | K182818 | 000 |
| 04042409398223 | K182818 | 000 |
| 04042409398216 | K182818 | 000 |
| 04042409398209 | K182818 | 000 |
| 04042409398193 | K182818 | 000 |
| 04042409398186 | K182818 | 000 |
| 04042409398179 | K182818 | 000 |
| 04042409398162 | K182818 | 000 |
| 04042409398155 | K182818 | 000 |
| 04042409398148 | K182818 | 000 |
| 04042409398131 | K182818 | 000 |
| 04042409398124 | K182818 | 000 |
| 04042409398117 | K182818 | 000 |
| 04042409398100 | K182818 | 000 |
| 04042409398094 | K182818 | 000 |
| 04042409398087 | K182818 | 000 |
| 04042409385490 | K182818 | 000 |