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U.S. Department of Health and Human Services

Product Classification

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Device resorbable spinal intervertebral body fixation orthosis - plate
Regulation Description Spinal intervertebral body fixation orthosis.
Definition Maintain position of bone graft in spinal fusion procedures. Intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts or autografts, in conjunction with traditional rigid fixation.
Physical State Plates and screws made from resorbable materials such polylactic acid
Technical Method Attaches to anterior column of spine using screws
Target Area anterior column of lumbar or cervical spine
Regulation Medical Specialty Orthopedic
Review Panel Orthopedic
Product CodeOJB
Premarket Review Spinal Devices (DHT6B)
Spinal Devices (DHT6B)
Submission Type 510(k)
Regulation Number 888.3060
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