Navio BBT Footpedal

Navio BBT Footpedal
Navio - PFSR120031

An assembly of electromechanical devices designed to be used during computer assisted surgery (CAS) as a functional extension of the surgeon for precise bone and soft-tissue modelling or soft-tissue removal (e.g., during a total knee joint arthroplasty (TKA)). It is computer-based and typically consists of an operator’s console and robotic arms for instrument manipulation. The input to a computer is usually by means of an existing computed tomography (CT) or magnetic resonance imaging (MRI) scan. It can also be used as a training aid for surgeons from a variety of specialities.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

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: 00885556628485

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