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 |