- Physicians Office Resource

SMART TSF.COM
SMART TSF - 71075401

Device Description

A stand-alone software application designed provide algorithms to assist a physician/surgeon in performing calculations to help create a schedule for the regular adjustment of an external orthopaedic fixation frame (framework) to help facilitate optimum bone growth for fracture healing. This software performs the necessary mathematical calculations and may provide a visual example of the skeletal deformities. It is intended to be installed on an off-the-shelf computer/smart device as an aid to the clinical judgement of a physician/surgeon in a clinic or hospital environment.

Environmental Conditions

No Data Available

Device Sizes

No Data Available

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: OSN

Device Name: Software For Diagnosis/Treatment

Device Class: 2

Physical State: Custom written or off the shelf software intended to be used with an orthopedic trauma device

Definition: Software associated with an orthopedic trauma device which is intended for the diagnosis or treatment of traumatic or reconstructive orthopedic conditions

Submission Type ID: 1

Review Panel: OR

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Software operated by the manufacturer or end user intended to diagnose or treat an orthopedic condition

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: Y

Target Area: Musculoskeletal system

Regulation Number: 888.3030

Third Party Flag: N

Medical Specialty: OR

Device Identifiers

Device Id: 00885556746370

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

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