Stryker EVEREST. Lumbar Pedicle Screw System. ROD. Two-Level. Catalog #101-65570

Vendor/Manufacturer: Stryker Product/Product Line: EVEREST Rod Vendor/Manufacturer Catalog #: 101-65570 Global Unique Device (GUD) Primary Device Identifier Number: 10888857006836 Global Unique Device (GUD) Device Description: Contoured Rod Global Medical Device Nomenclature (GMDN) Preferred Term Name: Bone-screw internal spinal fixation system, non-sterile Category 1: Spine Category 2: Lumbar Pedicle Screw Systems Category 3: Rod Category 4: Two Level Quantity of "Each"es needed in each System/Set: 2 FDA Regulation Medical Specialty: Orthopedic Devices - Prosthetic Devices FDA Regulation Number: 888.3070 FDA Regulation Description Classification Name: Thoracolumbosacral pedicle screw system FDA Classification Product Code: NKB FDA Classification Product Code Device Name: Thoracolumbosacral Pedicle Screw System FDA Premarket Submissions: K181603 SUBSTANTIALLY EQUIVALENT to the following products: 1. RANGE (MESA and DENALI) Spinal System 2. CASPIAN OCT (MESA Mini and DENALI Mini) Spinal System 3. YUKON OCT Spinal System