56393b83-5542-4b43-9d0d-e5b10e6d34d7UpdatePublished72025-11-202021-06-302021-12-31Not in Commercial DistributionB562SEFSS320PrimaryHIBCCEpiFIXSEFSS32SEFSS32062355158Wishbone Medical, Inc.14.5mm x 32mm EpiFIX Solid Screw, SS, T20 Head falsefalsefalsefalsefalsetruetruefalsetruetruefalsefalsetrueLabeling does not contain MRI Safety InformationtruefalseK18270400046647Orthopaedic fixation plate, non-bioabsorbableA non-bioabsorbable, non-customized, firm, implantable sheet intended to stabilize a fractured orthopaedic bone (excluding craniofacial and spinal) to treat a traumatic/pathological fracture, to fuse a joint (arthrodesis) and/or as part of an osteotomy. Typically attached to a bone of a limb, rib, sternum, or pelvis, it is designed to be fixed in place with screws, and may be used in connection with another fixation plate; it does not incorporate a sleeve or blade. Disposable instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be packaged with the plate.trueActiveOBTPlate, Bone, Growth Control, Pediatric, Epiphysiodesistruefalse