The following data is part of a premarket notification filed by Aap Implantate Ag with the FDA for Loqteq Distal Lateral Femur Plate 4.5 (left And Right Version) Loqreq Cortical Screw 4.5 T25, Self-tapping.
| Device ID | K121494 |
| 510k Number | K121494 |
| Device Name: | LOQTEQ DISTAL LATERAL FEMUR PLATE 4.5 (LEFT AND RIGHT VERSION) LOQREQ CORTICAL SCREW 4.5 T25, SELF-TAPPING |
| 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 | 2012-05-21 |
| Decision Date | 2012-11-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04042409393570 | K121494 | 000 |
| 04042409219856 | K121494 | 000 |
| 04042409219863 | K121494 | 000 |
| 04042409219870 | K121494 | 000 |
| 04042409219887 | K121494 | 000 |
| 04042409219894 | K121494 | 000 |
| 04042409219900 | K121494 | 000 |
| 04042409219917 | K121494 | 000 |
| 04042409219924 | K121494 | 000 |
| 04042409219931 | K121494 | 000 |
| 04042409220258 | K121494 | 000 |
| 04042409220272 | K121494 | 000 |
| 04042409393563 | K121494 | 000 |
| 04042409219849 | K121494 | 000 |