FairFix Adjustable Button System
FDA 510(k) K222169 · Medacta International S.A.
510(k) numberK222169
Submission
- Device name
- FairFix Adjustable Button System
- Applicant
- Medacta International S.A.
Castel San Pietro (Ch), CH - Received
- July 21, 2022
- Decision date
- August 16, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 FairFix Adjustable Button System cleared by the FDA?
FairFix Adjustable Button System (K222169) received a 510(k) decision of Substantially Equivalent on August 16, 2022, 26 days after the submission was received.
What is the product code of K222169?
The FDA product code is MBI – Fastener, Fixation, Nondegradable, Soft Tissue, a Class II (moderate risk) device regulated under 21 CFR 888.3040.