Sintea Biotech Schanz Screw, Model Tfx.Ss.Xx.X
FDA 510(k) K031154 · Sintea Biotech, Inc.
510(k) numberK031154
Submission
- Device name
- Sintea Biotech Schanz Screw, Model Tfx.Ss.Xx.X
- Applicant
- Sintea Biotech, Inc.
Miami Beach, FL, US - Received
- April 11, 2003
- Decision date
- June 24, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JDW – Pin, Fixation, Threaded
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code JDW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260073 | XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mmJDW · Special | Biodynamik, Inc. | 02/10/2026SE |
| K250316 | Meduloc Intramedullary Fracture Fixation (IFF) SystemJDW · Traditional | Meduloc, LLC | 10/29/2025SE |
| K241357 | XT3 SystemJDW · Traditional | Biodynamik, Inc. | 01/22/2025SE |
| K223112 | MAVERICK Mini External Fixation SystemJDW · Traditional | Smith & Nephew, Inc. | 12/08/2022SE |
| K213874 | MAVERICK External Fixation SystemJDW · Traditional | Smith & Nephew, Inc. | 02/11/2022SE |
| K211508 | Steinmann Pins and Kirschner WiresJDW · Traditional | Stryker GmbH | 10/05/2021SE |
| K210784 | Extended HA Half PinsJDW · Special | Smith & Nephew, Inc. | 04/02/2021SE |
| K200933 | Syntec Non-Sterile Steinmann Pins SystemJDW · Special | Syntec Scientific Corporation | 05/05/2020SE |
| K191803 | Orthopedic Fixation PinJDW · Traditional | Tinavi (Anhui) Medical Technologies Co., Ltd. | 04/14/2020SE |
| K192768 | Temporary Fixation PinsJDW · Traditional | Eisertech, LLC | 12/26/2019SE |
More from Eisertech, LLC
| 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 |
| K020085 | Sintea Biotech Posterior Lumbar System, Model PLS 00.T5.XMNH · Traditional | 12/10/2002SE |
| K022065 | Sintea Biotech Traumafix System, Model TFX.00.00.XJEC · Traditional | 08/06/2002SE |
Questions and answers
When was Sintea Biotech Schanz Screw, Model Tfx.Ss.Xx.X cleared by the FDA?
Sintea Biotech Schanz Screw, Model Tfx.Ss.Xx.X (K031154) received a 510(k) decision of Substantially Equivalent on June 24, 2003, 74 days after the submission was received.
What is the product code of K031154?
The FDA product code is JDW – Pin, Fixation, Threaded, a Class II (moderate risk) device regulated under 21 CFR 888.3040.