The following data is part of a premarket notification filed by Aap Implantate Ag with the FDA for Loqteq Distal Fibula Plate 3.5, Cancellous Screw 4.0, Washer.
| Device ID | K161703 |
| 510k Number | K161703 |
| Device Name: | LOQTEQ Distal Fibula Plate 3.5, Cancellous Screw 4.0, Washer |
| 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 |
| Subsequent Product Code | HTN |
| Subsequent Product Code | HWC |
| 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 | 2016-11-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EATO430290SINGLE9 | K161703 | 000 |
| 04042409353154 | K161703 | 000 |
| 04042409353161 | K161703 | 000 |
| 04042409353178 | K161703 | 000 |
| 04042409353185 | K161703 | 000 |
| 04042409353192 | K161703 | 000 |
| 04042409353208 | K161703 | 000 |
| 04042409353215 | K161703 | 000 |
| 04042409353222 | K161703 | 000 |
| 04042409353147 | K161703 | 000 |
| 04042409353130 | K161703 | 000 |
| 04042409352652 | K161703 | 000 |
| 04042409353062 | K161703 | 000 |
| 04042409353079 | K161703 | 000 |
| 04042409353086 | K161703 | 000 |
| 04042409353093 | K161703 | 000 |
| 04042409353109 | K161703 | 000 |
| 04042409353116 | K161703 | 000 |
| 04042409353123 | K161703 | 000 |
| 04042409353239 | K161703 | 000 |
| 04042409353246 | K161703 | 000 |
| 04042409355516 | K161703 | 000 |
| 04042409355523 | K161703 | 000 |
| 04042409355530 | K161703 | 000 |
| 04042409355547 | K161703 | 000 |
| 04042409355554 | K161703 | 000 |
| 04042409362668 | K161703 | 000 |
| 04042409360176 | K161703 | 000 |
| EATO4302909 | K161703 | 000 |
| 04042409355509 | K161703 | 000 |
| 04042409354984 | K161703 | 000 |
| 04042409353253 | K161703 | 000 |
| 04042409354915 | K161703 | 000 |
| 04042409354922 | K161703 | 000 |
| 04042409354939 | K161703 | 000 |
| 04042409354946 | K161703 | 000 |
| 04042409354953 | K161703 | 000 |
| 04042409354960 | K161703 | 000 |
| 04042409354977 | K161703 | 000 |
| 04042409352614 | K161703 | 000 |