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510(k) K162237

XO1 Knee Balancing System by Xpandortho, Inc. — Product Code ONN

K162237 is an FDA 510(k) premarket notification submitted by Xpandortho, Inc. for the device "XO1 Knee Balancing System". The FDA issued a decision of Substantially Equivalent on April 25, 2017. The device falls under product code ONN (Intraoperative Orthopedic Joint Assessment Aid), a Class II device regulated under 21 CFR 882.4560.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 25, 2017
Date Received
August 9, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Intraoperative Orthopedic Joint Assessment Aid
Device Class
Class II
Regulation Number
882.4560
Review Panel
OR
Submission Type

Measurement and interpretation of orthopedic joint information.

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FDA data resources