- Physicians Office Resource

ACUTE QC STRUT BAND
Acute QC Strut and Components - 71935871

Device Description

An assembly of devices designed to stabilize fractured bones to promote treatment and healing. It typically consists of an external plastic and/or metallic fixator (a framework) and other external and/or implantable components such as clamps, rods, rings, pins, bolts, and nuts, as well as some reusable instrumentation (e.g., wrenches, depth gauge, tensioner). It is used mainly to help the healing of long bones such as the femur, tibia and humerus, as well as fractures of the foot and ankle, joint fusions, and limb lengthening. This is a single-use device.

Environmental Conditions

No Data Available

Device Sizes

No Data Available

Device Sterilization

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: KTT

Device Name: Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: OR

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: Y

Target Area: N/A

Regulation Number: 888.3030

Third Party Flag: N

Medical Specialty: OR

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: 20885556807105

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

Device Id: 00885556807101

Device Type: Unit of Use

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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