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U.S. Department of Health and Human Services

Product Classification
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Device anterior staple as supplemental fixation for fusion
Regulation Description Spinal intervertebral body fixation orthosis.
Definition Anterior cervical device for supplemental fixation to support a fusion.
Physical State This is a metalic staple that is implanted into two adjacent vertebral bodies.
Technical Method The staple provides physical support while a fusion develops between vertebral bodies.
Target Area This is intended for the anterior, cervical spinal column in skeletally mature patients.
Regulation Medical Specialty Orthopedic
Review Panel Orthopedic
Product CodePHQ
Premarket Review Office of Orthopedic Devices (OHT6)
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
Reporting		 Eligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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