FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
CORTICAL SCREW 3.5, T15, SELF-TAPPING, TITANIUM, CORTICAL SCREW 4.5, T25, SELF TAPPING, TITANIUM
K Number: K141949
·
Decision Sep 12, 2014
Classifications
1
FEI Numbers
659
Registration Numbers
659
Same Product Code
1058
Applicant Total
37
Review Days
56
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- CORTICAL SCREW 3.5, T15, SELF-TAPPING, TITANIUM, CORTICAL SCREW 4.5, T25, SELF TAPPING, TITANIUM
- K Number
- K141949
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Aap Implantate AG
- Date Received
- July 18, 2014
- Decision Date
- September 12, 2014
- Product Code
- HWC
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HWC | Screw, Fixation, Bone | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HWC), ordered by most recent decision date.
VEOFIX Snap Off Screw
FDA 510(k)
FDA Class 2
·Orthopedic
CoLink® & CoLag® Non-Sterile Screws
FDA 510(k)
FDA Class 2
·Orthopedic
TriMed Compression Screws
FDA 510(k)
FDA Class 2
·Orthopedic
Arthrex Beaming System
FDA 510(k)
FDA Class 2
·Orthopedic
OSSIOfiber® Threaded Trimmable Fixation Nail
FDA 510(k)
FDA Class 2
·Orthopedic
TITAN Nail; APTUS K-Wire System
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Aap Implantate AG
| K Number | Device Name | ||
|---|---|---|---|
| K254253 | LOQTEQ® VA Proximal Humerus Plate 3.5 | Mar 24, 2026 | Substantially Equivalent |
| K233008 | Cannulated Headless Bone Screws | Jun 5, 2024 | Substantially Equivalent |
| K230141 | LOQTEQ® VA Elbow Plates 2.7/3.5 System | Mar 17, 2023 | Substantially Equivalent |
| K211582 | LOQTEQ Proximal Humerus Plate 3.5 System | Oct 18, 2021 | Substantially Equivalent |
| K210043 | LOQTEQ Distal Lateral Femur Plate 4.5 System | Mar 3, 2021 | Substantially Equivalent |
| K182818 | LOQTEQ VA Calcaneus Plate 3.5 | Aug 1, 2019 | Substantially Equivalent |
| K182785 | LOQTEQ VA Foot Plates 2.5 | Jun 19, 2019 | Substantially Equivalent |
| K161696 | aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5 | Nov 23, 2016 | Substantially Equivalent |
| K161747 | 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 | Nov 22, 2016 | Substantially Equivalent |
| K161703 | LOQTEQ Distal Fibula Plate 3.5, Cancellous Screw 4.0, Washer | Nov 4, 2016 | Substantially Equivalent |