LOQTEQ®
GUDID 04042409256707
LOQTEQ® Prox. Humerus Plate 3.5, 14 holes, L 221 Titanium
aap Implantate AG
Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile| Primary Device ID | 04042409256707 |
| NIH Device Record Key | de579477-084f-4792-96e8-936375134697 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | LOQTEQ® |
| Version Model Number | PH 3510-14-2 |
| Company DUNS | 328420633 |
| Company Name | aap Implantate AG |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04042409256707 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K211582
FDA Product Code
| HRS | Plate, Fixation, Bone |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[04042409256707]
Moist Heat or Steam Sterilization
[04042409256707]
Moist Heat or Steam Sterilization
[04042409256707]
Moist Heat or Steam Sterilization
[04042409256707]
Moist Heat or Steam Sterilization
[04042409256707]
Moist Heat or Steam Sterilization
[04042409256707]
Moist Heat or Steam Sterilization
[04042409256707]
Moist Heat or Steam Sterilization
[04042409256707]
Moist Heat or Steam Sterilization
[04042409256707]
Moist Heat or Steam Sterilization
[04042409256707]
Moist Heat or Steam Sterilization
[04042409256707]
Moist Heat or Steam Sterilization
[04042409256707]
Moist Heat or Steam Sterilization
[04042409256707]
Moist Heat or Steam Sterilization
[04042409256707]
Moist Heat or Steam Sterilization
[04042409256707]
Moist Heat or Steam Sterilization
[04042409256707]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-11-17 |
| Device Publish Date | 2021-11-09 |
On-Brand Devices [LOQTEQ® ]
| 04042409419386 | LOQTEQ® VA Foot 2.5, screw caddy, empty |
| 04042409419324 | LOQTEQ® VA Foot 2.5, insert 2 for correction plates, empty |
| 04042409419300 | LOQTEQ® VA Foot 2.5, insert 1 for fracture plates, empty |
| 04042409419287 | LOQTEQ® VA Foot 2.5, basic tray for implants |
| 04042409419249 | LOQTEQ® VA Foot 2.5, insert for instruments |
| 04042409419225 | LOQTEQ® VA Foot 2.5, basic tray for instruments |
| 04042409419201 | Lid for tray, 247 x 362mm |
| 04042409403620 | Drill guide LOQTEQ VA with scale to L 40, drill ø2.0, 0° |
| 04042409393723 | Drill guide LOQTEQ VA w. handle, drill ø2.7, 0°-15°, long |
| 04042409383700 | Drill guide LOQTEQ VA with thread, drill ø2.7, 0° to 15° |
| 04042409380129 | Drill guide LOQTEQ VA w. handle, drill ø2.7, 0°-15°, short |
| 04042409363405 | Drill guide LOQTEQ VA with thread, L 50, drill ø2.0, 0° |
| 04042409363399 | Drill guide LOQTEQ VA with thread, L 40, drill ø2.0, 0° |
| 04042409363375 | Drill guide LOQTEQ VA with scale to L 28, drill ø2.0, 0° |
| 04042409363368 | Drill guide LOQTEQ VA with thread, drill ø2.0, 0° to 15° |
| 04042409363351 | Drill guide LOQTEQ VA with handle, drill ø2.0, 0° to 15° |
| 04042409259913 | Basic insert for load drill guide, LOQTEQ 4.5, round hole |
| 04042409256387 | Drill guide for distal Femur MIS LOQTEQ 4.5 |
| 04042409253706 | Drill guide LOQTEQ 2.7 scale to L75, drill ø2.0 light blue |
| 04042409253690 | Drill guide LOQTEQ 2.7 scale to L30, drill ø2.0 light blue |
| 04042409244704 | Drill guide for gliding hole LOQTEQ 4.5, I-ø 4.2, red, long |
| 04042409234231 | Drill guide for round hole LOQTEQ 3.5, ID 2.4, green |
| 04042409221521 | Load Drill guide LOQTEQ 4.5, compression 2mm |
| 04042409221514 | Load Drill guide LOQTEQ 4.5, compression 1mm |
| 04042409220333 | Drill guide for round hole LOQTEQ 4.5, I-ø 4.2, blue, long |
| 04042409213083 | Drill guide for round hole LOQTEQ 4.5, I-ø 3.9, blue |
| 04042409213076 | Drill guide for gliding hole LOQTEQ 4.5, ID 3.9, red |
| 04042409213007 | Load drill guide LOQTEQ 4.5,adjustable up to 2mm |
| 04042409212994 | Basic insert for load drill guide LOQTEQ 4.5 |
| 04042409208188 | Basic Insert for Load Drill Guide LOQTEQ 3.5 |
| 04042409208171 | Load Drill guide LOQTEQ 3.5, compression 2mm |
| 04042409208164 | Load Drill guide LOQTEQ 3.5, compression 1mm |
| 04042409208157 | Load Drill guide LOQTEQ 3.5, adjustable up to 2mm |
| 04042409208140 | Drill guide for round hole LOQTEQ 3.5, ID 2.8, blue |
| 04042409208133 | Drill guide for gliding hole LOQTE® 3.5, ID 2.8, red |
| 04042409360534 | LOQTEQ® Distal Lateral Humerus Plate, 11 holes, L 205, L Titanium |
| 04042409393242 | LOQTEQ® Dist. Lateral Femur Plate 4.5, 7/17 holes, L 386, L Titanium |
| 04042409393235 | LOQTEQ® Dist. Lateral Femur Plate 4.5, 7/15 holes, L 350, L Titanium |
| 04042409393228 | LOQTEQ® Dist. Lateral Femur Plate 4.5, 7/17 holes, L 386, R Titanium |
| 04042409393211 | LOQTEQ® Dist. Lateral Femur Plate 4.5, 7/15 holes, L 350, R Titanium |
| 04042409423567 | LOQTEQ® VA Calcaneus 3.5, complete set Titanium |
| 04042409395352 | LOQTEQ® VA Calcaneus 3.5, complete set Titanium |
| 04042409385605 | LOQTEQ® VA Calcaneus Plate 3.5 w/o tab, L 70, L Titanium |
| 04042409385599 | LOQTEQ® VA Calcaneus Plate 3.5 w/o tab, L 60, L Titanium |
| 04042409385582 | LOQTEQ® VA Calcaneus Plate 3.5 w/o tab, L 70, R Titanium |
| 04042409385575 | LOQTEQ® VA Calcaneus Plate 3.5 w/o tab, L 60, R Titanium |
| 04042409385520 | LOQTEQ® VA Calcaneus Plate 3.5, L 70, L Titanium |
| 04042409385513 | LOQTEQ® VA Calcaneus Plate 3.5, L 60, L Titanium |
| 04042409385506 | LOQTEQ® VA Calcaneus Plate 3.5, L 70, R Titanium |
| 04042409385490 | LOQTEQ® VA Calcaneus Plate 3.5, L 60, R Titanium |
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 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.