Partially Threaded Bone Fix. Pin
FDA 510(k) K842293 · Warsaw Orthopedic, Inc.
510(k) numberK842293
Submission
- Device name
- Partially Threaded Bone Fix. Pin
- Applicant
- Warsaw Orthopedic, Inc.
Mchenry, IL, US - Received
- June 13, 1984
- Decision date
- August 2, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
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|---|---|---|
| K892877 | Cradle, Hospital Bed ClothingFNJ · Traditional | 06/15/1989SE |
| K883784 | TSRH Anterior Spinal Screws, Staples and End PlateLYQ · Traditional | 04/06/1989SN |
| K883783 | TSRH Sacral Spinal ScrewKWP · Traditional | 04/06/1989SN |
| K880212 | TSRH H/M Hook Holder W/Rod MoverKWP · Traditional | 03/04/1988SE |
| K880211 | TSRH H/M Hook HolderKWP · Traditional | 03/04/1988SE |
| K880215 | TSRH H/M Hook, Eyebolt/Lock Nut Assem., Spinal RodKWP · Traditional | 02/18/1988SE |
| K880214 | TSRH H/M Torque Limiting WrenchKWP · Traditional | 02/18/1988SE |
| K870843 | Schultz Phalangeal Comp Trial/Metacarpal Comp TriaHWT · Traditional | 05/27/1987SE |
| K870842 | Schultz Phalangeal Comp Rasp/Metacarpal Comp RaspHTP · Traditional | 05/27/1987SE |
| K870830 | Warsaw Orthopedic TSR Cross Link SystemKWP · Traditional | 05/04/1987SE |
Questions and answers
When was Partially Threaded Bone Fix. Pin cleared by the FDA?
Partially Threaded Bone Fix. Pin (K842293) received a 510(k) decision of Substantially Equivalent on August 2, 1984, 50 days after the submission was received.
What is the product code of K842293?
The FDA product code is JDW – Pin, Fixation, Threaded, a Class II (moderate risk) device regulated under 21 CFR 888.3040.