Advanced Intramedullary Nail System
FDA 510(k) K221221 · Double Medical Technology, Inc.
510(k) numberK221221
Submission
- Device name
- Advanced Intramedullary Nail System
- Applicant
- Double Medical Technology, Inc.
Xiamen, CN - Received
- April 27, 2022
- Decision date
- December 21, 2022
- 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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| 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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| K221150 | Advanced Bone PlateHRS · Traditional | 01/25/2023SE |
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| K221090 | Metal Cannulated ScrewHWC · Traditional | 01/10/2023SE |
| K220921 | Metal Bone ScrewHWC · Traditional | 12/12/2022SE |
| K172830 | Double Medical Femoral Nail SystemHSB · Traditional | 08/24/2018SE |
| K172828 | Double Medical Cage SystemMAX · Traditional | 02/01/2018SE |
Questions and answers
When was Advanced Intramedullary Nail System cleared by the FDA?
Advanced Intramedullary Nail System (K221221) received a 510(k) decision of Substantially Equivalent on December 21, 2022, 238 days after the submission was received.
What is the product code of K221221?
The FDA product code is HSB – Rod, Fixation, Intramedullary And Accessories, a Class II (moderate risk) device regulated under 21 CFR 888.3020.