Vendor/Manufacturer: Alphatec Spine, Inc. / ATEC Spine
Product/Product Line: Alphatec Spine Navigation Instruments
FDA Regulation Medical Specialty: Neurological Devices - Neurological Surgical Devices
FDA Regulation Number: 882.4560
FDA Regulation Description Classification Name:
Stereotaxic Instrument
FDA Classification Product Code: OLO
FDA Classification Product Code Device Name:
Orthopedic Stereotaxic Instrument
SUBSTANTIALLY EQUIVALENT to the following products:
Device Description:
The Alphatec NAV Instruments are Class II, manual, surgical instruments for use with Medtronic SteathStation Navigation system to assist surgeons in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures for preparation and placement of pedicle screw system implants. This surgical imaging technology provides surgeons visualization for complex and MIS procedures and confirms the accuracy of advanced surgical procedures. Use of these navigation systems provides the surgeon access to real-time, multi-plane 3D images (and 2D images) providing confirmation of hardware placement.
Indications for Use:
Alphatec Spine Navigated Reusable Instruments are intended to be used during the preparation and placement of Alphatec screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. Alphatec Spine Navigated Reusable Instruments are specifically designed for use with the Medtronic StealthStation System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, along bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.
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