The following data is part of a premarket notification filed by Aap Implantate Ag with the FDA for Aap Loqteq Distal Medial Tibia Plate 3.5 System.
| Device ID | K113601 |
| 510k Number | K113601 |
| Device Name: | AAP LOQTEQ DISTAL MEDIAL TIBIA PLATE 3.5 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 | 2012-11-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04042409214479 | K113601 | 000 |
| 04042409212512 | K113601 | 000 |
| 04042409212536 | K113601 | 000 |
| 04042409212543 | K113601 | 000 |
| 04042409212550 | K113601 | 000 |
| 04042409212567 | K113601 | 000 |
| 04042409212574 | K113601 | 000 |
| 04042409212581 | K113601 | 000 |
| 04042409212598 | K113601 | 000 |
| 04042409212604 | K113601 | 000 |
| 04042409212611 | K113601 | 000 |
| 04042409212628 | K113601 | 000 |
| 04042409212505 | K113601 | 000 |