XO1 Knee Balancing System
K-Number: K162237 · 2017-04-25
ApplicantXpandortho, Inc.
Decision Date2017-04-25
Product CodeONN
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
XO1 Knee Balancing System is a medical device manufactured by Xpandortho, Inc.. It received FDA 510(k) clearance on 2017-04-25 under approval number K162237. 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 XO1 Knee Balancing System?
XO1 Knee Balancing System is a medical device that received FDA 510(k) clearance on 2017-04-25. It is manufactured by Xpandortho, Inc.. The 510(k) number is K162237.
When was XO1 Knee Balancing System approved by the FDA?
XO1 Knee Balancing System received FDA 510(k) clearance on 2017-04-25, under approval number K162237.
What company makes XO1 Knee Balancing System?
XO1 Knee Balancing System is manufactured by Xpandortho, Inc..
What is the FDA product code for XO1 Knee Balancing System?
The FDA product code for XO1 Knee Balancing System is ONN.
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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.