TEMPLATE NAV4360030 30MM EXTENDED

TEMPLATE NAV4360030 30MM EXTENDED
T2 STRATOSPHERE™ Expandable Corpectomy System - NAV4360030

A hand-held manual surgical instrument designed to connect to and hold an implant (e.g., bone screw, bone graft), trial implant, or implantable device sizer/template (e.g., glenoid defect sizer, hearing implant template) to facilitate guidance, gauging/sizing, and/or monitoring of the held device during orthopaedic or ear/nose/throat (ENT) surgery. The instrument is typically made of metal or synthetic polymer materials and is typically constructed in the form of a long shaft with a handle at the proximal end and a device holding/fixation mechanism at the distal end. This is a reusable device.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: True

Sterilization Methods:

• Moist Heat or Steam Sterilization

Code: OLO

Device Name: Orthopedic Stereotaxic Instrument

Device Class: 2

Physical State: Device consists of Camera, computer, various shaped tracking arrays, computer interface for commmunication between user and device.

Definition: Stereotaxic guidance during orthopedic surgery procedures. Indicated for Orthopedic joint or spine surgery. Neurological stereotaxic instruments are classified under product code HAW.

Submission Type ID: 1

Review Panel: OR

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: User loads Computer software pre-Op to plan surgery procedure, then registers the patient anatomy during surgery to allow software to track patient anatomy, implants, and surgical tools in real time/space.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Orthopedic joints and spinal procedures where tracking of instrumentation is desired.

Regulation Number: 882.4560

Third Party Flag: N

Medical Specialty: NE

Device Id: 00643169611825

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A