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U.S. Department of Health and Human Services

Product Classification

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Device sacroiliac joint fixation
Regulation Description Smooth or threaded metallic bone fixation fastener.
Definition sacroiliac joint fusion
Physical State may be used with bone graft, should not be used with bone cement
Technical Method bridges both sides of the joint, preventing motion
Target Area sacroiliac joint
Regulation Medical Specialty Orthopedic
Review Panel Orthopedic
Product CodeOUR
Premarket Review Spinal Devices (DHT6B)
Spinal Devices (DHT6B)
Submission Type 510(k)
Regulation Number 888.3040
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? Yes
Life-Sustain/Support Device? No
Recognized Consensus Standards
Third Party Review Not Third Party Eligible