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U.S. Department of Health and Human Services

Product Classification
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Device cerclage, fixation
Regulation Description Bone fixation cerclage.
Regulation Medical Specialty Orthopedic
Review Panel Orthopedic
Product CodeJDQ
Premarket Review Spinal Devices (DHT6B)
Spinal Devices (DHT6B)
Submission Type 510(k)
Regulation Number 888.3010
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Recognized Consensus Standards
Third Party Review Not Third Party Eligible
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