FitboneTM Trochanteric
K-Number: K250112 · 2025-04-10
ApplicantOrthofix Srl
Decision Date2025-04-10
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
FitboneTM Trochanteric is a medical device manufactured by Orthofix Srl. It received FDA 510(k) clearance on 2025-04-10 under approval number K250112. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the FitboneTM Trochanteric?
FitboneTM Trochanteric is a medical device that received FDA 510(k) clearance on 2025-04-10. It is manufactured by Orthofix Srl. The 510(k) number is K250112.
When was FitboneTM Trochanteric approved by the FDA?
FitboneTM Trochanteric received FDA 510(k) clearance on 2025-04-10, under approval number K250112.
What company makes FitboneTM Trochanteric?
FitboneTM Trochanteric is manufactured by Orthofix Srl.
What is the FDA product code for FitboneTM Trochanteric?
The FDA product code for FitboneTM Trochanteric is HSB.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.