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Sign in to claim this brandaap Implantate AG
US
Last updated May 24, 2026
What aap Implantate AG makes
The company manufactures orthopaedic fixation hardware, including non-bioabsorbable plates, non-sliding bone screws, and implantable bone washers. It also produces reusable surgical tools such as drill guides, depth gauges, instrument trays, and aiming/guiding attachments, alongside implant racks for organized storage. These products are designed for use in orthopaedic procedures requiring precise fixation and instrument organization.
The portfolio includes devices classified as Class I and Class II under FDA regulations, with all products listed in the FDA’s Unique Device Identifier (UDI) database. The company operates from the United States, adhering to applicable regulatory standards for medical devices in that jurisdiction.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does aap Implantate AG manufacture?
aap Implantate AG specializes in orthopaedic fixation hardware and reusable surgical tools. Their products include non-bioabsorbable orthopaedic fixation plates and non-sliding bone screws, which are used to stabilize bone fractures or surgical sites. They also produce implantable bone washers, surgical drill guides, depth gauges, instrument trays, aiming/guiding block attachments, and implant racks for organized storage. These devices are designed to support precise orthopaedic procedures and improve surgical workflow efficiency.
Where is aap Implantate AG based, and what regulatory standards do they follow?
aap Implantate AG is based in the United States. As a manufacturer, they develop devices that comply with FDA regulations, including classification under Class I and Class II categories. Since their products are listed in the FDA’s Unique Device Identifier (UDI) database, they adhere to U.S. requirements for medical device registration, labeling, and post-market surveillance to ensure safety and performance.
Which regulatory registries or databases list aap Implantate AG’s devices?
aap Implantate AG’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system is a standardized way to identify medical devices throughout their distribution and use, ensuring traceability and regulatory compliance. This listing helps healthcare providers, regulators, and other stakeholders verify device details like manufacturer information, model names, and regulatory classifications.
How are aap Implantate AG’s devices classified under FDA regulations?
aap Implantate AG’s devices fall into two primary FDA classification categories: Class I and Class II. Class I devices generally pose the lowest risk and are subject to general controls, while Class II devices require additional regulatory controls due to moderate risk. For example, reusable surgical tools like drill guides or depth gauges may be classified as Class II because they require validation of safety and performance, whereas simpler fixation hardware like non-sliding screws might fall under Class I due to lower inherent risk.
What is the purpose of the reusable surgical tools produced by aap Implantate AG?
The reusable surgical tools from aap Implantate AG, such as drill guides, depth gauges, instrument trays, and aiming/guiding attachments, are designed to enhance precision and efficiency in orthopaedic surgeries. These tools help surgeons achieve accurate implant placement, reduce human error, and maintain sterile conditions by organizing instruments during procedures. Reusability also supports cost-effectiveness and sustainability by minimizing waste, though they must undergo rigorous cleaning and sterilization processes to ensure safety between uses.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- aap.de
- —
- —
- [email protected]
- Phone
- +4930750190
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 328420633
Catalogue (760)
Page 15 of 16| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Loqteq® | SK 2530-32-2 | FDA UDI | Class II | Active |
| Loqteq® | PA 3564-04-2 | EUDAMEDFDA UDI | Class II | Active |
| Loqteq® | IC 6950-26 | EUDAMEDFDA UDI | Class I | Active |
| Loqteq® | SK 4525-75-2 | FDA UDI | Class II | Active |
| Loqteq® | PU 3534-04-2 | FDA UDI | Class II | Active |
| Loqteq® | PK 3522-07-2 | FDA UDI | Class II | Active |
| Loqteq® | PK 3532-07-2 | FDA UDI | Class II | Active |
| Loqteq® | IC 6955-21 | EUDAMEDFDA UDI | Class I | Active |
| Loqteq® | SK 4525-16-2 | FDA UDI | Class II | Active |
| Loqteq® | SP 3825-42-2 | FDA UDI | Class II | Active |
| Loqteq® | SK 4526-85-2 | FDA UDI | Class II | Active |
| Loqteq® | IU 8176-01 | FDA UDI | Class I | Active |
| Loqteq® | IL 1000-06 | EUDAMEDFDA UDI | Class I | Active |
| Loqteq® | SK 4526-26-2 | FDA UDI | Class II | Active |
| Loqteq® | IC 6934-42 | FDA UDI | Class I | Active |
| Loqteq® | SK 3526-28-2 | FDA UDI | Class II | Active |
| Loqteq® | SK 4527-12-2 | FDA UDI | Class II | Active |
| Loqteq® | PA 3541-17-2 | FDA UDI | Class II | Active |
| Loqteq® | SK 4526-90-2 | FDA UDI | Class II | Active |
| Loqteq® | IU 8173-01 | FDA UDI | Class I | Active |
| Loqteq® | PR 2522-03-2 | FDA UDI | Class II | Active |
| Loqteq® | IL 1002-03 | EUDAMEDFDA UDI | Class I | Active |
| Loqteq® | PH 3510-06-2 | FDA UDI | Class II | Active |
| Aap Loqtec(r) Olecranon Plate | K140607 | FDA 510(k) | Class II | Active |
| aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5 | K161696 | EUDAMEDFDA 510(k)FDA UDI | Class II | Active |
| Aap Cannulated Screws | K021233 | FDA 510(k) | Class II | Active |
| Loqteq Distal Dorsolateral Humerus Plate | K132787 | FDA 510(k) | Class II | Active |
| Loqteq Small Fragment Set Loqteq Cortical Screw3.5, Small Head, T15, Self Tapping Loqteq Cortical Screw 3.5, T15, Self T | K113652 | FDA 510(k) | Class II | Active |
| Cannulated Headless Bone Screws | K233008 | FDA 510(k) | Class II | Active |
| Aap Loqtec Clavicle Plates 2.7/3.5 | K141823 | FDA 510(k) | Class II | Active |
| 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 | K161747 | FDA 510(k) | Class II | Active |
| Aap Loqteq Proximal Lateral Tibia Plate 4.5 System | K113602 | FDA 510(k) | Class II | Active |
| LOQTEQ VA Foot Plates 2.5 | K182785 | FDA 510(k) | Class II | Active |
| LOQTEQ® VA Proximal Humerus Plate 3.5 | K254253 | FDA 510(k) | Class II | Active |
| aap LOQTEQ VA Radius Set 2.5 | K153034 | FDA 510(k) | Class II | Active |
| Loqteq Large Fragment Set Loqteq Cortical Screw 4.5, Small Head, T25, Self Tapping Loqteq Cortical Screw 4.5, T25, Self | K113648 | FDA 510(k) | Class II | Active |
| LOQTEQ VA Calcaneus Plate 3.5 | K182818 | FDA 510(k) | Class II | Active |
| Loqteq High Tibia Osteotomy Plate 4.5 | K131782 | FDA 510(k) | Class II | Active |
| LOQTEQ® VA Elbow Plates 2.7/3.5 System | K230141 | FDA 510(k) | Class II | Active |
| aap Cortical Screw 1.5, self-tapping, aap Cortical Screw 1.5, self-tapping, Titanium | K150974 | FDA 510(k) | Class II | Active |
| LOQTEQ Distal Lateral Femur Plate 4.5 System | K210043 | FDA 510(k) | Class II | Active |
| Aap K-Wire, Steinmann Pin, Cerclage Wire | K131459 | FDA 510(k) | Class II | Active |
| Cortical Screw 3.5, T15, Self-Tapping, Titanium, Cortical Screw 4.5, T25, Self Tapping, Titanium | K141949 | FDA 510(k) | Class II | Active |
| Aequos | K033260 | FDA 510(k) | Class II | Active |
| Aap Acroplate | K030909 | FDA 510(k) | Class II | Active |
| Loqteq Distal Lateral Femur Plate 4.5 (left And Right Version) Loqreq Cortical Screw 4.5 T25, Self-Tapping | K121494 | FDA 510(k) | Class II | Active |
| Loqteq Proximal Humerus Plate 3.5, Short Loqteq Proximal Humerus Plate 3.5, Long | K121495 | FDA 510(k) | Class II | Active |
| Aap Loqteq Distal Medial Tibia Plate 3.5 System | K113601 | FDA 510(k) | Class II | Active |
| Aap Cannulated Screw 2.0 | K130590 | FDA 510(k) | Class II | Active |
| Aap Cannulated Screw And Darco Headed Screw | K080101 | FDA 510(k) | Class II | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Aap Implantate Ag BERLIN · DE FEI 3001406084