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U.S. Department of Health and Human Services

Product Classification

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Device tester, stiffness, cartilage, arthroscopic
Regulation Description Arthroscope.
Regulation Medical Specialty Orthopedic
Review Panel Orthopedic
Product CodeNGR
Premarket Review Restorative, Repair and Trauma Devices (DHT6C)
Restorative, Repair and Trauma Devices (DHT6C)
Submission Type 510(k)
Regulation Number 888.1100
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
Accredited Persons
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