Ilizarov External Fixation System
FDA 510(k) K962808 · Smith & Nephew Richards, Inc.
510(k) numberK962808
Submission
- Device name
- Ilizarov External Fixation System
- Applicant
- Smith & Nephew Richards, Inc.
Memphis, TN, US - Received
- July 18, 1996
- Decision date
- August 19, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KTT – Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
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| K260900 | DYNEX® External Fixation SystemsKTT · Special | Vilex, LLC | 04/17/2026SE |
| K260112 | QuikFix External Fixator: Knee-Spanning PackKTT · Traditional | Stabiliz Orthopaedics, Inc. | 03/23/2026SE |
| K253291 | Excelsior SystemKTT · Traditional | Blue Ocean Global | 01/20/2026SE |
| K253613 | Monkey Rings External Ring Fixation SystemKTT · Special | Paragon 28, Inc. | 12/19/2025SE |
| K253202 | Hoffmann LRF SystemKTT · Traditional | Stryker GmbH | 12/19/2025SE |
| K252555 | Medusa Orthopedics Boa External Fixation SystemKTT · Traditional | Medusa Orthopedics, LLC | 11/25/2025SE |
| K252625 | The Response Ortho Smart Fixator - Hexapod SystemKTT · Traditional | Response Ortho Solutions, LLC | 11/20/2025SE |
| K252106 | External Fixation Mini Rail SystemKTT · Traditional | Paragon 28, Inc. | 09/30/2025SE |
| K251862 | External Fixation Bone DistractorKTT · Traditional | Paragon 28, Inc. | 08/11/2025SE |
More from Paragon 28, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K965224 | Empower Anterior Direct ScrewsKWP · Traditional | 05/08/1997SE |
| K963509 | Global Taper Tapered Hip System, GT SpectronLPH · Traditional | 01/27/1997SE |
| K960444 | Finn Rod to Rod ConnectorKWP · Traditional | 01/24/1997SE |
| K964163 | Trimax Nail SystemHSB · Traditional | 12/27/1996SE |
| K962557 | Genesis II Zirconium Femoral Component/Profix Zirconium Femoral ComponentJWH · Traditional | 12/05/1996SN |
| K963486 | Revision Hip SystemJDI · Traditional | 11/27/1996SE |
| K962541 | Reflection Acetabular Reinforcement RingsJDJ · Traditional | 09/17/1996SE |
| K962137 | Genesis II Constrained SystemJWH · Traditional | 08/02/1996SE |
| K955767 | Cofied Modular Shoulder SystemKWS · Traditional | 04/08/1996SN |
| K960094 | Reflection Dual Dimension ShellMBL · Traditional | 03/27/1996SE |
Questions and answers
When was Ilizarov External Fixation System cleared by the FDA?
Ilizarov External Fixation System (K962808) received a 510(k) decision of Substantially Equivalent on August 19, 1996, 32 days after the submission was received.
What is the product code of K962808?
The FDA product code is KTT – Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, a Class II (moderate risk) device regulated under 21 CFR 888.3030.