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U.S. Department of Health and Human Services

Product Classification
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Device intervertebral fusion device with integrated fixation, lumbar
Regulation Description Intervertebral body fusion device.
Definition Intended to stabilize lumbar spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.
Physical State Hollow cylinder or rectangular box made of metal or polymer with integrated fixation.
Technical Method Acts as a disc spacer and holds bone graft; also includes some form of integrated fixation to maintain stability by direct purchase into the bony vertebral endplates.
Target Area Intervertebral disc space
Regulation Medical Specialty Orthopedic
Review Panel Orthopedic
Product CodeOVD
Premarket Review Office of Orthopedic Devices (OHT6)
Spinal Devices (DHT6B)
Submission Type 510(k)
Regulation Number 888.3080
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
Guidance Document
Third Party Review Not Third Party Eligible
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