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U.S. Department of Health and Human Services

Product Classification

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Device sterilization wrap containers, trays, cassettes & other accessories
Regulation Medical Specialty General Hospital
Review Panel Orthopedic
Product CodeKCT
Premarket Review Orthopedic Devices (OHT6)
Spinal Devices (DHT6B)
Submission Type 510(k)
Regulation Number 880.6850
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
Recognized Consensus Standard
Third Party Review
Accredited Persons
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