Osteo Steinmann Pin
FDA 510(k) K922194 · Osteo AG
510(k) numberK922194
Submission
- Device name
- Osteo Steinmann Pin
- Applicant
- Osteo AG
Greenwood, SC, US - Received
- May 11, 1992
- Decision date
- July 23, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
|---|---|---|
| K933340 | Osteo Interlocking-Compression NailHSB · Traditional | 06/30/1994SE |
| K922196 | Osteo Tibia NailHSB · Traditional | 07/23/1992SE |
| K922195 | Osteo Femoral NailHSB · Traditional | 07/23/1992SE |
| K922193 | Osteo Kirschner WireHTY · Traditional | 07/23/1992SE |
| K920149 | Osteo Ex-Fi-ReJEC · Traditional | 04/09/1992SE |
| K920037 | Osteo Compression Hip ScrewHRC · Traditional | 03/11/1992SE |
| K914374 | Osteo Cerclage WireJDQ · Traditional | 12/30/1991SE |
| K913559 | Osteo Complete Pneumatic Drill-OscilairHSZ · Traditional | 11/07/1991SE |
Questions and answers
When was Osteo Steinmann Pin cleared by the FDA?
Osteo Steinmann Pin (K922194) received a 510(k) decision of Substantially Equivalent on July 23, 1992, 73 days after the submission was received.
What is the product code of K922194?
The FDA product code is HTY – Pin, Fixation, Smooth, a Class II (moderate risk) device regulated under 21 CFR 888.3040.