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U.S. Department of Health and Human Services

Product Classification
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Device intraoperative orthopedic joint assessment aid
Regulation Description Stereotaxic instrument.
Definition Measurement and interpretation of orthopedic joint information.
Physical State Measurement transducer, central processing unit, and user interface.
Technical Method The system analytically measures the joint state and interprets the measurements using a software algorithm to aid in the positioning of an implant system.
Target Area Orthopedic joint.
Regulation Medical Specialty Neurology
Review Panel Orthopedic
Product CodeONN
Premarket Review Office of Orthopedic Devices (OHT6)
Restorative, Repair and Trauma Devices (DHT6C)
Submission Type 510(k)
Regulation Number 882.4560
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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