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510(k) Data Aggregation
K Number
K062572Device Name
CRANIOTECH BONE TRANSPORT RECONSTRUCTION PLATE
Manufacturer
Date Cleared
2007-05-11
(253 days)
Product Code
Regulation Number
872.4760Why did this record match?
Applicant Name (Manufacturer) :
CUSTOM SCIENTIFIC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Craniotech Bone Transport Reconstruction Plate (BTRP) system includes devices intended as a bone stabilizer, lengthening and/or transport device when correction of congenital or developmental bone deficiencies or post-traumatic or post-surgical defects of the mandible (including ramus, body, alveolar ridge, symphisis) and mid-face bones require gradual distraction.
Device Description
The device contains a reconstruction plate and screws of TiAl6V4 titanium alloy, and a stainless steel bone transport unit, activation screw and flexible cable.
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