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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 non-fusion spinous process spacer devices
Definition The devices are intended to manipulate tissue or implant materials for the positioning, alignment, placement, or removal of spinous process spacer devices for non-fusion use.
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 Spinous process
Regulation Medical Specialty Orthopedic
Review Panel Orthopedic
Product CodeQLR
Premarket Review Office of Orthopedic Devices (OHT6)
Spinal Devices (DHT6B)
Submission Type 510(k)
Regulation Number 888.4520
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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