Wristjack System (Remanufactured), Sterile and Non-Sterile, Models CFD-147-RS, CFD-247-RNS
FDA 510(k) K030519 · Hand Biomechanics Lab, Inc.
510(k) numberK030519
Submission
- Device name
- Wristjack System (Remanufactured), Sterile and Non-Sterile, Models CFD-147-RS, CFD-247-RNS
- Applicant
- Hand Biomechanics Lab, Inc.
Sacramento, CA, US - Received
- February 19, 2003
- Decision date
- June 10, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JEC – Component, Traction, Invasive
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
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| K082679 | Laki Hand Fixation System, Model TFX.3X.06.XJEC · Special | Sintea Biotech, Inc. | 04/07/2009SE |
| K072432 | F3 Fractured Finger Fixator, Sterile (Model: FCS 400) and Non SterileJEC · Traditional | Hand Biomechanics Lab, Inc. | 01/09/2008SE |
More from Hand Biomechanics Lab, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K252020 | TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade AssemblyHRX · Traditional | 10/15/2025SE |
| K222490 | HBL Blade AssemblyHRX · Traditional | 11/14/2022SE |
| K181192 | PIP FixJEC · Traditional | 10/22/2018SE |
| K072432 | F3 Fractured Finger Fixator, Sterile (Model: FCS 400) and Non SterileJEC · Traditional | 01/09/2008SE |
| K033112 | Wristjack Orif System, Wristjack Orif System, Non-Sterile, Models CFD-347, CFD-347-NSKTT · Traditional | 11/05/2003SE |
| K992970 | Digit WidgetJDW · Traditional | 11/08/1999SE |
| K984442 | Agee-Wristjack Fracture Reaction System (Sterile Version), Model CFD-147JEC · Traditional | 02/12/1999SE |
| K942906 | Agee-Wristjack Pre-Drill KitHTW · Traditional | 12/22/1994SE |
Questions and answers
When was Wristjack System (Remanufactured), Sterile and Non-Sterile, Models CFD-147-RS, CFD-247-RNS cleared by the FDA?
Wristjack System (Remanufactured), Sterile and Non-Sterile, Models CFD-147-RS, CFD-247-RNS (K030519) received a 510(k) decision of Substantially Equivalent on June 10, 2003, 111 days after the submission was received.
What is the product code of K030519?
The FDA product code is JEC – Component, Traction, Invasive, a Class II (moderate risk) device regulated under 21 CFR 888.3040.