Osteo Femoral Nail
FDA 510(k) K922195 · Osteo AG
510(k) numberK922195
Submission
- Device name
- Osteo Femoral Nail
- 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
- HSB – Rod, Fixation, Intramedullary And Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3020
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code HSB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261481 | Pangea Femur Reconstruction SystemHSB · Traditional | Stryker GmbH | 06/29/2026SE |
| K261651 | Precice Max System and Precice Ankle Salvage SystemHSB · Special | NuVasive Specialized Orthopedics | 06/18/2026SE |
| K253080 | AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)HSB · Traditional | Suzhou and Science & Technology Development Corp. | 06/18/2026SE |
| K253155 | Fule Metallic Lockable Intramedullary Nail SystemsHSB · Traditional | Beijing Fule Science & Technology Development… | 06/17/2026SE |
| K253046 | HERA Interlocking Intramedullary Nailing SystemHSB · Traditional | ZheJiang Decans Medical Devices Co., Ltd. | 06/16/2026SE |
| K260146 | Fitbone® Transport and Lengthening SystemHSB · Traditional | Orthofix Srl | 05/19/2026SE |
| K253991 | Fitbone Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAAHSB · Traditional | Orthofix Srl | 05/08/2026SE |
| K261043 | AUTOBAHN Nailing SystemHSB · Special | Globus Medical, Inc. | 04/24/2026SE |
| K252016 | Arthrex Humeral NailsHSB · Traditional | Arthrex, Inc. | 03/20/2026SE |
| K252961 | Fusion FibFix NailHSB · Traditional | Fusion Orthopedics USA, LLC | 03/18/2026SE |
More from Fusion Orthopedics USA, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K933340 | Osteo Interlocking-Compression NailHSB · Traditional | 06/30/1994SE |
| K922196 | Osteo Tibia NailHSB · Traditional | 07/23/1992SE |
| K922194 | Osteo Steinmann PinHTY · 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 Femoral Nail cleared by the FDA?
Osteo Femoral Nail (K922195) 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 K922195?
The FDA product code is HSB – Rod, Fixation, Intramedullary And Accessories, a Class II (moderate risk) device regulated under 21 CFR 888.3020.