Steinman Pin, Thread
FDA 510(k) K903266 · Onyx Medical Corp.
510(k) numberK903266
Submission
- Device name
- Steinman Pin, Thread
- Applicant
- Onyx Medical Corp.
Memphis, TN, US - Received
- July 24, 1990
- Decision date
- July 30, 1990
- 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 |
More from Eisertech, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K041679 | Cold Light; Cold Light MD; Gossamer DermlightILY · Abbreviated | 12/16/2004SE |
| K942022 | Face-It ShieldLYU · Traditional | 07/08/1994SE |
| K931690 | Spoon PlateHRS · Traditional | 06/07/1994SN |
| K934614 | Mini Fragment PlateHRS · Traditional | 05/04/1994SN |
| K931692 | T-PlateHRS · Traditional | 05/04/1994SN |
| K931684 | Epiphysis PlateHRS · Traditional | 05/04/1994SN |
| K931680 | Cannulated Cancellous ScrewHWC · Traditional | 05/04/1994SN |
| K934616 | Cancellous Bone ScrewHWC · Traditional | 04/25/1994SN |
| K934615 | Cancellous Bone ScrewHWC · Traditional | 04/25/1994SN |
| K931790 | Cortical Bone ScrewHWC · Traditional | 04/25/1994SN |
Questions and answers
When was Steinman Pin, Thread cleared by the FDA?
Steinman Pin, Thread (K903266) received a 510(k) decision of Substantially Equivalent on July 30, 1990, 6 days after the submission was received.
What is the product code of K903266?
The FDA product code is JDW – Pin, Fixation, Threaded, a Class II (moderate risk) device regulated under 21 CFR 888.3040.