Rush Pin
FDA 510(k) K905341 · O'Tec Corp.
510(k) numberK905341
Submission
- Device name
- Rush Pin
- Applicant
- O'Tec Corp.
Memphis, TN, US - Received
- November 28, 1990
- Decision date
- December 11, 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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| K262722 | Primal K-Wire (P99-193-1410)HTY · Special | Paragon 28, Inc. | 08/28/2026SE |
| 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 |
|---|---|---|
| K943293 | SCC22/ SCC26 Shower Commode ChairIOR · Traditional | 08/19/1994SE |
| K910093 | Futura Femoral Hip StemJDI · Traditional | 07/01/1991SE |
| K905358 | Cancellous ScrewHWC · Traditional | 01/04/1991SN |
| K905357 | Cortical Bone Screw (European Style)HWC · Traditional | 01/04/1991SN |
| K905355 | Broad Self-Compressing PlateHRS · Traditional | 01/04/1991SN |
| K905347 | Hagie PinJDW · Traditional | 01/04/1991SN |
| K905333 | U.S. Type Cruciate Slot Bone ScrewHWC · Traditional | 01/04/1991SN |
| K905364 | Round StapleJDR · Traditional | 12/11/1990SE |
| K905363 | Fixation StapleJDR · Traditional | 12/11/1990SE |
| K905362 | Barbed Square StapleJDR · Traditional | 12/11/1990SE |
Questions and answers
When was Rush Pin cleared by the FDA?
Rush Pin (K905341) received a 510(k) decision of Substantially Equivalent on December 11, 1990, 13 days after the submission was received.
What is the product code of K905341?
The FDA product code is HTY – Pin, Fixation, Smooth, a Class II (moderate risk) device regulated under 21 CFR 888.3040.