cd7b2bbe-ca63-4ecd-bfca-9959c0494b04UpdatePublished42025-07-022016-09-01In Commercial Distribution00842048106951PrimaryGS1Hyper-C Anterior Cervical Plate System0203-4515F0203-4515F078812602DEGEN MEDICAL, INC.1Bone Screw, Self Drilling, 4.6 X 15 FixedfalsefalsefalsefalsefalsetruetruefalsefalsefalsefalsefalsefalseLabeling does not contain MRI Safety InformationtruefalseK15075900061325Bone-screw internal spinal fixation system, non-sterileAn assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.falseObsoleteKWQAPPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODYOuter DiameterLengthfalsetrueMoist Heat or Steam Sterilization