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U.S. Department of Health and Human Services

Product Classification
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Device manual instruments designed for use with total disc replacement devices
Definition The devices are intended to manipulate tissue or implant materials for the positioning, alignment, defect creation, placement, or removal of total disc replacement devices.
Physical State Manual, non-powered surgical tools with implant-specific geometry.
Technical Method Manual surgical instrument that assembles to the associated implant or has features that manipulate tissue to reproduce the geometry of the associated implant.
Target Area Spinal vertebral body.
Regulation Medical Specialty Orthopedic
Review Panel Orthopedic
Product CodeQLQ
Premarket Review Office of Orthopedic Devices (OHT6)
Spinal Devices (DHT6B)
Submission Type 510(k)
Regulation Number 888.4515
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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