XO1 Knee Balancing System— 510(k) K162237

Substantially Equivalent

Xpandortho, Inc.

FDA 510(k) clearance K162237 for XO1 Knee Balancing System, Substantially Equivalent on 2017-04-25. Applicant: Xpandortho, Inc..

Clearance details

Applicant: Xpandortho, Inc.
Product code: Code ONN
Advisory panel: Neurology
Date received: 2016-08-09
Decision date: 2017-04-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: La Jolla, CA, US

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