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U.S. Department of Health and Human Services

Product Classification
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Device patient specific manual navigation system
Regulation Description Stereotaxic instrument.
Definition Intended for defining implant alignment relative to a patient's anatomy.
Physical State Manual Instrument with auxiliary software.
Technical Method Pre-operative imagery is used to establish a correlation between the patient's anatomy and the instrument.
Target Area Orthopedic Joints
Regulation Medical Specialty Neurology
Review Panel Orthopedic
Product CodeOSE
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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