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510(k) Data Aggregation
K Number
K052605Device Name
EXTERNAL FIXATION
Manufacturer
GEXFIX USA INC.
Date Cleared
2005-11-10
(50 days)
Product Code
KTT
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
GEXFIX USA INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
1) BONE FRACTURE FIXATION
2) OSTEOTOMY
3) ARTHODESIS
4) CORRECTION OF DEFORMITY
5) REVISION PROCEDURES WHERE OTHER DEVICES HAVE BEE UNSUCCESSFUL
6) BONE RECONSTRUCTION PROCEDURES
Device Description
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