Syntec Femoral Nail Extended System
FDA 510(k) K202935 · Syntec Scientific Corporation
510(k) numberK202935
Submission
- Device name
- Syntec Femoral Nail Extended System
- Applicant
- Syntec Scientific Corporation
Chang Hua, TW - Received
- September 29, 2020
- Decision date
- October 28, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261481 | Pangea Femur Reconstruction SystemHSB · Traditional | Stryker GmbH | 06/29/2026SE |
| K261651 | Precice Max System and Precice Ankle Salvage SystemHSB · Special | NuVasive Specialized Orthopedics | 06/18/2026SE |
| K253080 | AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)HSB · Traditional | Suzhou and Science & Technology Development Corp. | 06/18/2026SE |
| K253155 | Fule Metallic Lockable Intramedullary Nail SystemsHSB · Traditional | Beijing Fule Science & Technology Development… | 06/17/2026SE |
| K253046 | HERA Interlocking Intramedullary Nailing SystemHSB · Traditional | ZheJiang Decans Medical Devices Co., Ltd. | 06/16/2026SE |
| K260146 | Fitbone® Transport and Lengthening SystemHSB · Traditional | Orthofix Srl | 05/19/2026SE |
| K253991 | Fitbone Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAAHSB · Traditional | Orthofix Srl | 05/08/2026SE |
| K261043 | AUTOBAHN Nailing SystemHSB · Special | Globus Medical, Inc. | 04/24/2026SE |
| K252016 | Arthrex Humeral NailsHSB · Traditional | Arthrex, Inc. | 03/20/2026SE |
| K252961 | Fusion FibFix NailHSB · Traditional | Fusion Orthopedics USA, LLC | 03/18/2026SE |
More from Fusion Orthopedics USA, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K202790 | Syntec Orthodontic Mini Screw Extended SystemOAT · Special | 09/17/2021SE |
| K200933 | Syntec Non-Sterile Steinmann Pins SystemJDW · Special | 05/05/2020SE |
| K191617 | Syntec Tibial Nail SystemHSB · Traditional | 09/03/2019SE |
| K181296 | Syntec Femoral Nail SystemHSB · Traditional | 04/11/2019SE |
| K161327 | Syntec Humeral Nail SystemHSB · Traditional | 06/08/2017SE |
| K111189 | Syntec Dental ImplantDZE · Traditional | 12/20/2012SE |
| K101971 | Syntec Os Spinal Fixation SystemNKB · Traditional | 03/25/2011SE |
| K092889 | Syntec Osteo-Plate and Screw FixationHRS · Traditional | 06/25/2010SE |
| K090476 | Syntec Orthodontic Mini ScrewOAT · Traditional | 06/18/2009SE |
| K090839 | Modification to Syntec-Taichun Non-Sterile Bone Plate and Screw ImplantsHRS · Special | 04/24/2009SE |
Questions and answers
When was Syntec Femoral Nail Extended System cleared by the FDA?
Syntec Femoral Nail Extended System (K202935) received a 510(k) decision of Substantially Equivalent on October 28, 2020, 29 days after the submission was received.
What is the product code of K202935?
The FDA product code is HSB – Rod, Fixation, Intramedullary And Accessories, a Class II (moderate risk) device regulated under 21 CFR 888.3020.