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U.S. Department of Health and Human Services

Product Classification

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Device bone, heterograft
Regulation Description Bone heterograft.
Definition Bone heterograft is a device intended to be implanted that is made from mature (adult) bovine bones and used to replace human bone following surgery in the cervical region of the spinal column.
Regulation Medical Specialty Orthopedic
Review Panel Orthopedic
Product CodeNVC
Premarket Review Office of Device Evaluation (ODE)
Division of Orthopedic Devices (DOD)
Joint and Fixation Devices Branch Two ¿ Hips/Wrists/Fingers (JFDB2)
Submission Type PMA
Regulation Number 888.3015
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible