The following data is part of a premarket notification filed by Aap Implantate Ag with the FDA for Aap Loqteq Proximal Lateral Tibia Plate 4.5 System.
| Device ID | K113602 |
| 510k Number | K113602 |
| Device Name: | AAP LOQTEQ PROXIMAL LATERAL TIBIA PLATE 4.5 SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | AAP IMPLANTATE AG LORENZWEG 5 Berlin, DE 12099 |
| Contact | Marc Seegers |
| Correspondent | Marc Seegers 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 | 2011-12-05 |
| Decision Date | 2012-10-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04042409213205 | K113602 | 000 |
| 04042409213113 | K113602 | 000 |
| 04042409213120 | K113602 | 000 |
| 04042409213137 | K113602 | 000 |
| 04042409213144 | K113602 | 000 |
| 04042409213151 | K113602 | 000 |
| 04042409213168 | K113602 | 000 |
| 04042409213175 | K113602 | 000 |
| 04042409213182 | K113602 | 000 |
| 04042409213199 | K113602 | 000 |
| 04042409213106 | K113602 | 000 |