LOQTEQ® VA Distal Tibia Plate System: LOQTEQ® VA Distal Medial Tibia Plate 3.5; LOQTEQ® VA Distal Anterolateral Tibia Plate 3.5; LOQTEQ® VA Distal Fibula Plate 2.7/3.5
Plate, Fixation, Bone
Aap Implantate AG
The following data is part of a premarket notification filed by Aap Implantate Ag with the FDA for Loqteq® Va Distal Tibia Plate System: Loqteq® Va Distal Medial Tibia Plate 3.5; Loqteq® Va Distal Anterolateral Tibia Plate 3.5; Loqteq® Va Distal Fibula Plate 2.7/3.5.
Pre-market Notification Details
| Device ID | K161747 |
| 510k Number | K161747 |
| Device Name: | LOQTEQ® VA Distal Tibia Plate System: LOQTEQ® VA Distal Medial Tibia Plate 3.5; LOQTEQ® VA Distal Anterolateral Tibia Plate 3.5; LOQTEQ® VA Distal Fibula Plate 2.7/3.5 |
| Classification | Plate, Fixation, Bone |
| Applicant | aap Implantate AG Lorenzweg 5 Berlin, DE D-12099 |
| Contact | Reni Schaller |
| Correspondent | Reni Schaller aap Implantate AG Lorenzweg 5 Berlin, DE D-12099 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-24 |
| Decision Date | 2016-11-22 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04042409386077 | K161747 | 000 |
| 04042409385735 | K161747 | 000 |
| 04042409385728 | K161747 | 000 |
| 04042409385711 | K161747 | 000 |
| 04042409385704 | K161747 | 000 |
| 04042409385698 | K161747 | 000 |
| 04042409385681 | K161747 | 000 |
| 04042409385674 | K161747 | 000 |
| 04042409385667 | K161747 | 000 |
| 04042409355165 | K161747 | 000 |
| 04042409355158 | K161747 | 000 |
| 04042409355141 | K161747 | 000 |
| 04042409355134 | K161747 | 000 |
| 04042409355127 | K161747 | 000 |
| 04042409355110 | K161747 | 000 |
| 04042409355103 | K161747 | 000 |
| 04042409355097 | K161747 | 000 |
| 04042409355080 | K161747 | 000 |
| 04042409385742 | K161747 | 000 |
| 04042409385759 | K161747 | 000 |
| 04042409386060 | K161747 | 000 |
| 04042409386053 | K161747 | 000 |
| 04042409386046 | K161747 | 000 |
| 04042409386039 | K161747 | 000 |
| 04042409386022 | K161747 | 000 |
| 04042409386015 | K161747 | 000 |
| 04042409386008 | K161747 | 000 |
| 04042409385995 | K161747 | 000 |
| 04042409385988 | K161747 | 000 |
| 04042409385971 | K161747 | 000 |
| 04042409385964 | K161747 | 000 |
| 04042409385957 | K161747 | 000 |
| 04042409385940 | K161747 | 000 |
| 04042409385797 | K161747 | 000 |
| 04042409385780 | K161747 | 000 |
| 04042409385773 | K161747 | 000 |
| 04042409385766 | K161747 | 000 |
| 04042409355073 | K161747 | 000 |
Trademark Results [LOQTEQ]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 LOQTEQ 79115670 4290778 Live/Registered |
aap Implantate AG 2012-05-11 |
 LOQTEQ 79109269 4259778 Live/Registered |
aap Implantate AG 2012-01-26 |
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