Smith & Nephew Rail System
FDA 510(k) K090926 · Smith & Nephew, Inc.
510(k) numberK090926
Submission
- Device name
- Smith & Nephew Rail System
- Applicant
- Smith & Nephew, Inc.
Memphis, TN, US - Received
- April 2, 2009
- Decision date
- June 8, 2009
- 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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| K252129 | AETOS Shoulder System Stemless Humeral ProsthesisPKC · Traditional | 10/03/2025SE |
| K251627 | BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3…MBI · Special | 06/25/2025SE |
| K243608 | TRIGEN Stable Lock Nut & WasherJDS · Traditional | 06/12/2025SE |
| K250677 | LEGION Total Knee SystemJWH · Special | 04/02/2025SE |
| K250571 | CATALYSTEM Femoral StemsLZO · Special | 03/28/2025SE |
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Questions and answers
When was Smith & Nephew Rail System cleared by the FDA?
Smith & Nephew Rail System (K090926) received a 510(k) decision of Substantially Equivalent on June 8, 2009, 67 days after the submission was received.
What is the product code of K090926?
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.