PEDIATRIC MANDIBULAR DISTRACTOR 2
NA - 62-02333
Device Description
A non-powered 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. 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.
Environmental Conditions
No Data Available
Device Sizes
- Height: 5.0 Millimeter
- Length: 70.0 Millimeter
- 3D Plates: 3x3 Holes
- Width: 30.0 Millimeter
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
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 IdentifiersDevice Id: 07613327291322
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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