G-Force Tenodesis Screw
FDA 510(k) K083150 · Wrightmedicaltechnologyinc
510(k) numberK083150
Submission
- Device name
- G-Force Tenodesis Screw
- Applicant
- Wrightmedicaltechnologyinc
Arlington, TN, US - Received
- October 24, 2008
- Decision date
- January 15, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MBI – Fastener, Fixation, Nondegradable, Soft Tissue
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
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Questions and answers
When was G-Force Tenodesis Screw cleared by the FDA?
G-Force Tenodesis Screw (K083150) received a 510(k) decision of Substantially Equivalent on January 15, 2009, 83 days after the submission was received.
What is the product code of K083150?
The FDA product code is MBI – Fastener, Fixation, Nondegradable, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3040.