The following data is part of a premarket notification filed by Aap Implantate Ag with the FDA for Aap Loqteq Proximal Medial Tibia Plate 3.5.
Device ID | K132554 |
510k Number | K132554 |
Device Name: | AAP LOQTEQ PROXIMAL MEDIAL TIBIA PLATE 3.5 |
Classification | Plate, Fixation, Bone |
Applicant | AAP IMPLANTATE AG LORENZWEG 5 Berlin, DE 12099 |
Contact | Christian Zietsch |
Correspondent | Christian Zietsch AAP IMPLANTATE AG LORENZWEG 5 Berlin, DE 12099 |
Product Code | HRS |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-08-14 |
Decision Date | 2013-10-03 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04042409263200 | K132554 | 000 |
04042409250002 | K132554 | 000 |
04042409250057 | K132554 | 000 |
04042409250071 | K132554 | 000 |
04042409261954 | K132554 | 000 |
04042409261961 | K132554 | 000 |
04042409263095 | K132554 | 000 |
04042409263101 | K132554 | 000 |
04042409263118 | K132554 | 000 |
04042409263125 | K132554 | 000 |
04042409263132 | K132554 | 000 |
04042409263149 | K132554 | 000 |
04042409263156 | K132554 | 000 |
04042409263163 | K132554 | 000 |
04042409263170 | K132554 | 000 |
04042409263187 | K132554 | 000 |
04042409263194 | K132554 | 000 |
04042409249983 | K132554 | 000 |