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U.S. Department of Health and Human Services

Product Classification
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Device bone wedge
Regulation Description Single/multiple component metallic bone fixation appliances and accessories.
Definition Intended to be used with ancillary fixation for opening wedge osteotomies or fusion in the ankle, foot, proximal tibia.
Physical State Wedge with or without graft window made of metal or polymer
Technical Method A wedge that may act as a spacer and/or hold bone graft in opening wedge osteotomy procedures, column lengthening, or fusion
Target Area foot, ankle, proximal tibia
Regulation Medical Specialty Orthopedic
Review Panel Orthopedic
Product CodePLF
Premarket Review Office of Orthopedic Devices (OHT6)
Restorative, Repair and Trauma Devices (DHT6C)
Submission Type 510(k)
Regulation Number 888.3030
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 Standard
Third Party Review Not Third Party Eligible
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