WASTON Metallic Intramedullary Nail System
FDA 510(k) K151062 · Changzhou Waston Medical Appliance Co., Ltd.
510(k) numberK151062
Submission
- Device name
- WASTON Metallic Intramedullary Nail System
- Applicant
- Changzhou Waston Medical Appliance Co., Ltd.
Changzhou, CN - Received
- April 20, 2015
- Decision date
- December 17, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HSB – Rod, Fixation, Intramedullary And Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3020
- Specialty
- Orthopedic
- Implant
- Yes
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| K253080 | AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)HSB · Traditional | Suzhou and Science & Technology Development Corp. | 06/18/2026SE |
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| K253046 | HERA Interlocking Intramedullary Nailing SystemHSB · Traditional | ZheJiang Decans Medical Devices Co., Ltd. | 06/16/2026SE |
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| K252016 | Arthrex Humeral NailsHSB · Traditional | Arthrex, Inc. | 03/20/2026SE |
| K252961 | Fusion FibFix NailHSB · Traditional | Fusion Orthopedics USA, LLC | 03/18/2026SE |
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|---|---|---|
| K211197 | Disposable Endoscopic Cutter Stapler and CartridgeGDW · Traditional | 01/19/2023SE |
| K150684 | WASTON General Spinal SystemMNI · Traditional | 11/18/2015SE |
| K151057 | WASTON Metallic Bone Plate and Screw SystemsHRS · Traditional | 08/10/2015SE |
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Questions and answers
When was WASTON Metallic Intramedullary Nail System cleared by the FDA?
WASTON Metallic Intramedullary Nail System (K151062) received a 510(k) decision of Substantially Equivalent on December 17, 2015, 241 days after the submission was received.
What is the product code of K151062?
The FDA product code is HSB – Rod, Fixation, Intramedullary And Accessories, a Class II (moderate risk) device regulated under 21 CFR 888.3020.