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NA - 92-02322

An implantable or partially-implantable device intended to temporarily distract (force apart) the two bone surfaces of the mandible (the lower jawbone) or maxilla (the upper jawbone) during craniomaxillofacial (CMF) distraction. It functions as a single-patient bone lengthening/augmentation device for the correction of congenital deficiencies or post-traumatic defects when gradual bone augmentation is required. It typically consists of a metal tube in which a right- and left-hand threaded rod rotates and to which are attached two craniofacial fixation plates that are surgically screwed to either side of the fracture. A small tip guard may be included to protect against inadvertent rotation.

No Data Available

• Width: 15.0 Millimeter
• Length: 60.0 Millimeter
• Height: 5.0 Millimeter
• Number of Screw Holes: 15.0 Holes

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: MQN

Device Name: External Mandibular Fixator And/Or Distractor

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: DE

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: 872.4760

Third Party Flag: N

Medical Specialty: DE

Device Id: 07613327504415

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