FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5
K Number: K161696
·
Decision Nov 23, 2016
Classifications
1
FEI Numbers
519
Registration Numbers
519
Same Product Code
1313
Applicant Total
37
Review Days
156
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Basic Information
- Device Name
- aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5
- K Number
- K161696
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Aap Implantate AG
- Date Received
- June 20, 2016
- Decision Date
- November 23, 2016
- Product Code
- HRS
- 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 |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HRS), ordered by most recent decision date.
I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular Stability; I.T.S. Humeral Head Plate with Angular Stability; I.T.S. FR.O.H. Calcaneus Repair System; I.T.S. Pilonplate with Angular Stability; I.T.S. Olecranonplate with Angular Stability; I.T.S. Straight Plate with Angular Stability; I.T.S. Screw System; I.T.S. PRS Sacral Rod System; I.T.S. Fibula Plate PROlock with Angular Stability; I.T.S. Distal Humeral Plates with Angular Stability; I.T.S. LRS (L
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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 |
| 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 |
| K153034 | aap LOQTEQ VA Radius Set 2.5 | Jan 21, 2016 | Substantially Equivalent |