7be796c4-7efb-4cf9-a887-c09398d9ea5fUpdatePublished42019-04-232016-12-31In Commercial Distribution10705034196916PrimaryGS1MONARCH277050100277050100107105876DEPUY SPINE, LLC1MONARCH SPINE SYSTEM DISTRACTOR 6.35mmfalsetruefalsefalsefalsefalsetruefalsefalsefalsefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse+1(800)255-2500xx@xx.xx12696Orthopaedic implant inserter/extractor, reusableA hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) through application of a striking or screwing force. It is an instrument in a one-piece or modular configuration with a mechanism that will attach and/or lock to part of the implant, and a mechanism to apply the striking force (e.g., on a pad/flange) using a surgical hammer or a weight that can slide along a shaft, or a mechanism for twisting (screwing) (e.g., T-handle). This is a reusable device.falseActiveHWBEXTRACTORfalsetrueMoist Heat or Steam Sterilization