Device product

Robotic Arm Interactive Orthopedic System (RIO)

Z-1508-2016

April 30, 2014

Class II

Product summary

Firm: Mako Surgical Corporation
Event: Event 73202
Status: Terminated
Classification: Class II
Quantity: 249
Official record key: device-enforcement:Z-1508-2016

Official wording

Reason: Revision of the field manual

Code information: Catalog # 203900 & 207092 All lots

Distribution pattern: Worldwide Distribution - Nationwide Distribution and to the countries of : Australia, Italy, Japan, Hong Kong, Scotland, Germany, Turkey , Greece, Singapore, Taiwan and South Korea.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Revision of the field manual