The following data is part of a premarket notification filed by Aap Implantate Ag with the FDA for Aap Loqteq Distal Anterolateral Tibia Plate 3.5.
| Device ID | K133675 |
| 510k Number | K133675 |
| Device Name: | AAP LOQTEQ DISTAL ANTEROLATERAL 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 | 2013-11-29 |
| Decision Date | 2014-01-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04042409262876 | K133675 | 000 |
| 04042409262050 | K133675 | 000 |
| 04042409262838 | K133675 | 000 |
| 04042409262845 | K133675 | 000 |
| 04042409262852 | K133675 | 000 |
| 04042409262869 | K133675 | 000 |
| 04042409262883 | K133675 | 000 |
| 04042409262890 | K133675 | 000 |
| 04042409262913 | K133675 | 000 |
| 04042409262920 | K133675 | 000 |
| 04042409262937 | K133675 | 000 |
| 04042409262944 | K133675 | 000 |
| 04042409262951 | K133675 | 000 |
| 04042409262043 | K133675 | 000 |