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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Intraoperative Orthopedic Joint Assessment Aid
510(k) Number K162237
FOIA Releasable 510(k) K162237
Device Name XO1 Knee Balancing System
Applicant
Xpandortho, Inc.
2223 Avenida De La Playa
Suite 203
La Jolla,  CA  92037
Applicant Contact REBECCA K PINE
Correspondent
Xpandortho, Inc.
2223 Avenida De La Playa
Suite 203
La Jolla,  CA  92037
Correspondent Contact REBECCA PINE
Regulation Number882.4560
Classification Product Code
ONN  
Date Received08/09/2016
Decision Date 04/25/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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