f61c8add-b084-44b6-b34f-77061945a0b1NewPublished12025-06-302025-06-20In Commercial DistributionM697T08012201PrimaryHIBCCIrix-A Lumbar Integrated Fusion SystemT080-1220081224143Xtant Medical Holdings, Inc.1PLIERS INSERTER ONE PIECE, ASSEMBLYfalsetruefalsefalsefalsefalsetruefalsefalsefalsefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse1-888-886-9354CS@xtantmedical.com64479Surgical implant handling forcepsA hand-held manual surgical instrument with blades designed to grasp and manipulate a surgical implant (excluding sutures) during implantation; it is not intended for use on tissues, is not a dental or ophthalmic device, and is not a dedicated tissue clip applier. It is made of metal materials and may have one of various designs (e.g., tweezers-, scissors-, alligator-like) whereby the blades are designed to be opened/closed to handle a variety of implantable devices (e.g., orthopaedic joint prosthesis, breast implant, surgical mesh). This is a reusable device intended to be sterilized prior to use.falseActiveHWAImpactorfalsetrueMoist Heat or Steam Sterilization