Product Classification

• 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 Code: NVC
• Premarket Review: Restorative, Repair and Trauma Devices (DHT6C); Restorative, Repair and Trauma Devices (DHT6C)
• Submission Type: PMA
• Regulation Number: 888.3015
• Device Class: 3
• 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

• 11-197 ASTM F983-86 (Reapproved 2018)
  Standard Practice for Permanent Marking of Orthopaedic Implant Components
• 11-199 ASTM F565-04 (Reapproved 2018)
  Standard Practice for Care and Handling of Orthopedic Implants and Instruments
• 11-424 ASTM F983-24
  Standard Practice for Permanent Marking of Orthopaedic Implant Components
• 11-425 ASTM F565-21
  Standard Practice for Care and Handling of Orthopedic Implants and Instruments

Third Party Review

Not Third Party Eligible