Sintea Biotech Traumafix System, Model TFX.00.00.X
FDA 510(k) K022065 · Sintea Biotech, Inc.
510(k) numberK022065
Submission
- Device name
- Sintea Biotech Traumafix System, Model TFX.00.00.X
- Applicant
- Sintea Biotech, Inc.
Miami Beach, FL, US - Received
- June 25, 2002
- Decision date
- August 6, 2002
- 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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| K102885 | Hoffmann II External Fixation System Line Extension Model 4920-1-010, 4920-1-020…JEC · Special | Stryker Corp. | 01/14/2011SE |
| 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 |
|---|---|---|
| K082679 | Laki Hand Fixation System, Model TFX.3X.06.XJEC · Special | 04/07/2009SE |
| K081631 | Sintea Biotech PLS Multi-Axial ScrewsMNH · Special | 07/18/2008SE |
| K072198 | X-Void, SpiderHRX · Traditional | 06/06/2008SE |
| K070181 | Sintea Biotech Dsc/Alf Spinal System, DSC.XX.T5.XX, ALF.XX.T5.XXMQP · Traditional | 04/18/2007SE |
| K060513 | Sintea Biotech PLS Multi-Axial Screws, Model PLS.XX.T5.XKWP · Special | 03/10/2006SE |
| K043355 | Sintea Biotech Posterior Lumbar System with Polyaxial and Recovery Screws, Model…KWP · Special | 12/17/2004SE |
| K041989 | Sintea Biotech Anterior Plate System, Model ACP.XX.T5.XKWQ · Traditional | 09/16/2004SE |
| K031154 | Sintea Biotech Schanz Screw, Model Tfx.Ss.Xx.XJDW · Traditional | 06/24/2003SE |
| K020085 | Sintea Biotech Posterior Lumbar System, Model PLS 00.T5.XMNH · Traditional | 12/10/2002SE |
Questions and answers
When was Sintea Biotech Traumafix System, Model TFX.00.00.X cleared by the FDA?
Sintea Biotech Traumafix System, Model TFX.00.00.X (K022065) received a 510(k) decision of Substantially Equivalent on August 6, 2002, 42 days after the submission was received.
What is the product code of K022065?
The FDA product code is JEC – Component, Traction, Invasive, a Class II (moderate risk) device regulated under 21 CFR 888.3040.