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510(k) K220830

TrueBalance™ Surgical System by These Three Medical, LLC — Product Code ONN

K220830 is an FDA 510(k) premarket notification submitted by These Three Medical, LLC for the device "TrueBalance™ Surgical System". The FDA issued a decision of Substantially Equivalent on September 15, 2022. 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
September 15, 2022
Date Received
March 22, 2022
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