Aap K-Wire, Steinmann Pin, Cerclage Wire
FDA 510(k) K131459 · Aap Implantate AG
510(k) numberK131459
Submission
- Device name
- Aap K-Wire, Steinmann Pin, Cerclage Wire
- Applicant
- Aap Implantate AG
Berlin, DE - Received
- May 20, 2013
- Decision date
- October 17, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JDW – Pin, Fixation, Threaded
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code JDW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260073 | XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mmJDW · Special | Biodynamik, Inc. | 02/10/2026SE |
| K250316 | Meduloc Intramedullary Fracture Fixation (IFF) SystemJDW · Traditional | Meduloc, LLC | 10/29/2025SE |
| K241357 | XT3 SystemJDW · Traditional | Biodynamik, Inc. | 01/22/2025SE |
| K223112 | MAVERICK Mini External Fixation SystemJDW · Traditional | Smith & Nephew, Inc. | 12/08/2022SE |
| K213874 | MAVERICK External Fixation SystemJDW · Traditional | Smith & Nephew, Inc. | 02/11/2022SE |
| K211508 | Steinmann Pins and Kirschner WiresJDW · Traditional | Stryker GmbH | 10/05/2021SE |
| K210784 | Extended HA Half PinsJDW · Special | Smith & Nephew, Inc. | 04/02/2021SE |
| K200933 | Syntec Non-Sterile Steinmann Pins SystemJDW · Special | Syntec Scientific Corporation | 05/05/2020SE |
| K191803 | Orthopedic Fixation PinJDW · Traditional | Tinavi (Anhui) Medical Technologies Co., Ltd. | 04/14/2020SE |
| K192768 | Temporary Fixation PinsJDW · Traditional | Eisertech, LLC | 12/26/2019SE |
More from Eisertech, LLC
| 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 |
| K230141 | LOQTEQ® VA Elbow Plates 2.7/3.5 SystemHRS · Traditional | 03/17/2023SE |
| 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 |
Questions and answers
When was Aap K-Wire, Steinmann Pin, Cerclage Wire cleared by the FDA?
Aap K-Wire, Steinmann Pin, Cerclage Wire (K131459) received a 510(k) decision of Substantially Equivalent on October 17, 2013, 150 days after the submission was received.
What is the product code of K131459?
The FDA product code is JDW – Pin, Fixation, Threaded, a Class II (moderate risk) device regulated under 21 CFR 888.3040.