The following data is part of a premarket notification filed by Aap Implantate Ag with the FDA for Loqteq High Tibia Osteotomy Plate 4.5.
| Device ID | K131782 |
| 510k Number | K131782 |
| Device Name: | LOQTEQ HIGH TIBIA OSTEOTOMY PLATE 4.5 |
| 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 | 2013-06-17 |
| Decision Date | 2013-11-18 |
| Summary: | summary |