Sidekick Circular Fixator System: Struts and Hinges
FDA 510(k) K100137 · Wrightmedicaltechnologyinc
510(k) numberK100137
Submission
- Device name
- Sidekick Circular Fixator System: Struts and Hinges
- Applicant
- Wrightmedicaltechnologyinc
Arlington, TN, US - Received
- January 19, 2010
- Decision date
- June 10, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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Questions and answers
When was Sidekick Circular Fixator System: Struts and Hinges cleared by the FDA?
Sidekick Circular Fixator System: Struts and Hinges (K100137) received a 510(k) decision of Substantially Equivalent on June 10, 2010, 142 days after the submission was received.
What is the product code of K100137?
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.