Digit Widget
FDA 510(k) K992970 · Hand Biomechanics Lab, Inc.
510(k) numberK992970
Submission
- Device name
- Digit Widget
- Applicant
- Hand Biomechanics Lab, Inc.
Sacramento, CA, US - Received
- September 3, 1999
- Decision date
- November 8, 1999
- 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 |
|---|---|---|
| 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 |
| K030519 | Wristjack System (Remanufactured), Sterile and Non-Sterile, Models CFD-147-RS, CFD-247-RNSJEC · Traditional | 06/10/2003SE |
| 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 Digit Widget cleared by the FDA?
Digit Widget (K992970) received a 510(k) decision of Substantially Equivalent on November 8, 1999, 66 days after the submission was received.
What is the product code of K992970?
The FDA product code is JDW – Pin, Fixation, Threaded, a Class II (moderate risk) device regulated under 21 CFR 888.3040.