LOQTEQ® VA Elbow Plates 2.7/3.5 System
FDA 510(k) K230141 · Aap Implantate AG
510(k) numberK230141
Submission
- Device name
- LOQTEQ® VA Elbow Plates 2.7/3.5 System
- Applicant
- Aap Implantate AG
Berlin, DE - Received
- January 18, 2023
- Decision date
- March 17, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HRS – Plate, Fixation, Bone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code HRS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261647 | Tempo Plating System; Ultra Compression Screw SystemHRS · Traditional | Pace Surgical | 09/03/2026SE |
| K261830 | FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…HRS · Traditional | Ortler Global Tibbi Gerecler Anonim Sirketi | 08/28/2026SE |
| K262537 | Versalock Sterile Plating SystemHRS · Special | GM Dos Reis Industria e Comercio Ltda. | 08/19/2026SE |
| K260277 | Mikron Trauma Bone Plate& Screw SystemHRS · Traditional | Mikron Makina San. ve Tic. Ltd. Sti. | 08/13/2026SE |
| K261511 | Xpert AnkleHRS · Traditional | Newclip Technics | 07/28/2026SE |
| K261406 | Versalock Proximal Tibial Plating SystemHRS · Traditional | GM Dos Reis Industria e Comercio Ltda. | 07/21/2026SE |
| K262032 | TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion…HRS · Special | TriMed, Inc. | 07/16/2026SE |
| K261191 | Alians Elbow SHRS · Traditional | Newclip Technics | 07/08/2026SE |
| K261054 | RibPlate SystemHRS · Traditional | Stryker Leibinger GmbH & Co KG | 07/01/2026SE |
| K261351 | SALGINA 2.5mm Distal Radius SystemHRS · Traditional | Bonebridge AG | 06/26/2026SE |
More from Bonebridge AG
| 510(k) | Device | Decision |
|---|---|---|
| K254253 | LOQTEQ® VA Proximal Humerus Plate 3.5HRS · Traditional | 03/24/2026SE |
| K233008 | Cannulated Headless Bone ScrewsHWC · Traditional | 06/05/2024SE |
| K211582 | LOQTEQ Proximal Humerus Plate 3.5 SystemHRS · Traditional | 10/18/2021SE |
| K210043 | LOQTEQ Distal Lateral Femur Plate 4.5 SystemHRS · Traditional | 03/03/2021SE |
| K182818 | LOQTEQ VA Calcaneus Plate 3.5HRS · Traditional | 08/01/2019SE |
| K182785 | LOQTEQ VA Foot Plates 2.5HRS · Traditional | 06/19/2019SE |
| K161696 | aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5HRS · Traditional | 11/23/2016SE |
| K161747 | LOQTEQ® VA Distal Tibia Plate System: LOQTEQ® VA Distal Medial Tibia Plate 3.5; LOQTEQ®…HRS · Traditional | 11/22/2016SE |
| K161703 | LOQTEQ Distal Fibula Plate 3.5, Cancellous Screw 4.0, WasherHRS · Traditional | 11/04/2016SE |
| K153034 | aap LOQTEQ VA Radius Set 2.5HRS · Traditional | 01/21/2016SE |
Questions and answers
When was LOQTEQ® VA Elbow Plates 2.7/3.5 System cleared by the FDA?
LOQTEQ® VA Elbow Plates 2.7/3.5 System (K230141) received a 510(k) decision of Substantially Equivalent on March 17, 2023, 58 days after the submission was received.
What is the product code of K230141?
The FDA product code is HRS – Plate, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.