TrueBalance Surgical System
K-Number: K220830 · 2022-09-15
ApplicantThese Three Medical, LLC
Decision Date2022-09-15
Product CodeONN
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
TrueBalance Surgical System is a medical device manufactured by These Three Medical, LLC. It received FDA 510(k) clearance on 2022-09-15 under approval number K220830. The device is classified under product code ONN. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the TrueBalance Surgical System?
TrueBalance Surgical System is a medical device that received FDA 510(k) clearance on 2022-09-15. It is manufactured by These Three Medical, LLC. The 510(k) number is K220830.
When was TrueBalance Surgical System approved by the FDA?
TrueBalance Surgical System received FDA 510(k) clearance on 2022-09-15, under approval number K220830.
What company makes TrueBalance Surgical System?
TrueBalance Surgical System is manufactured by These Three Medical, LLC.
What is the FDA product code for TrueBalance Surgical System?
The FDA product code for TrueBalance Surgical System is ONN.
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Official Source
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