Steinman Pin
FDA 510(k) K903265 · Onyx Medical Corp.
510(k) numberK903265
Submission
- Device name
- Steinman Pin
- 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
- HTY – Pin, Fixation, Smooth
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
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| K253325 | ZipToe Hammertoe Fusion SystemHTY · Traditional | Toetal Solutions | 12/29/2025SE |
| K252657 | Impact PEEK Union Nail SystemHTY · Special | Nvision Biomedical Technologies, Inc. | 09/19/2025SE |
| K250315 | Ronavis FX (FX-001)HTY · Traditional | AIRS, Inc. | 08/01/2025SE |
| K251362 | PediFlex Flexible Nail SystemHTY · Traditional | OrthoPediatrics Corp. | 06/24/2025SE |
| K250646 | Impact PEEK Union Nail SystemHTY · Traditional | Nvision Biomedical Technologies | 06/11/2025SE |
| K241014 | Biomet Kirschner Wires (K-Wires)HTY · Traditional | Biomet, Inc. | 05/22/2024SE |
| K231272 | OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable…HTY · Traditional | OSSIO , Ltd. | 12/01/2023SE |
| K231147 | Hammerdesis Interphalangeal Fusion SystemHTY · Traditional | Intelivation | 09/14/2023SE |
| K230750 | OSSIOfiber® Cannulated Trimmable Fixation NailHTY · Traditional | OSSIO , Ltd. | 09/13/2023SE |
More from OSSIO , Ltd.
| 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 cleared by the FDA?
Steinman Pin (K903265) 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 K903265?
The FDA product code is HTY – Pin, Fixation, Smooth, a Class II (moderate risk) device regulated under 21 CFR 888.3040.