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 |