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510(k) Data Aggregation
K Number
K243419Device Name
Altus Spine Navigation System
Manufacturer
Altus Partners LLC.
Date Cleared
2025-05-08
(185 days)
Product Code
OLO
Regulation Number
882.4560Why did this record match?
Applicant Name (Manufacturer) :
Altus Partners LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Altus Spine Navigation System reusable instruments are indicated to be used during the preparation and placement of Altus Spine Valencia Pedicle Screw System and Altus Spine Monaco Pedicle Screw System screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The Altus Spine Navigation System reusable instruments are specifically designed for use with the Medtronic StealthStation® System S8, 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 vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.
• For a comprehensive summary of indications, the IFU for the specific system of use must be directly referenced: Altus Spine Valencia Pedicle Screw System / Altus Spine Monaco Pedicle Screw System.
The Altus Spine Navigation System is intended to pair with either the Altus Spine Valencia Pedicle Screw System or Altus Spine Monaco Pedicle Screw system to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine.
The Altus Spine Navigation system may be used for noncervical pedicle fixation via posterior percutaneous approach with MIS instrumentation.
Device Description
The Altus Spine Navigation System reusable instruments are surgical instruments for use with the Medtronic StealthStation® 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. The Altus Spine Navigation System includes the following instruments dedicated to screw placement: Screwdrivers and Taps. The Altus Spine Navigation System is to be used with the following Altus Spine Systems:
▪ Altus Spine Valencia Pedicle Screw System
▪ Altus Spine Monaco Pedicle Screw System
All instruments are made of stainless steel per ASTM F899. All instruments are reusable instruments provided non sterile. The Altus Spine Navigation System instruments are not compatible with implants from other manufacturers. The Altus Spine Navigation System are designed for use only with Medtronic StealthStation® System S8 (V2.1.0) and the Medtronic NavLock® Tracker System.
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