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510(k) Data Aggregation
K Number
K150009Device Name
Baide
Manufacturer
Date Cleared
2015-02-25
(54 days)
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
Jiangsu Baide Medical Intrument Co.,Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
BaiDe® locking plate system is intended for adult patients as indicated for fixation of tibia.
Device Description
BaiDe" locking plate system contains locking plates with various specifications, metal bone and locking screws with various specifications, and various specific instruments. The bone plates are used for fixation of bones. The screws are used for fix the plates on the bones and the instruments are used for completing the surgery.
The bone plates are manufactured from unalloyed titanium that conforms to ASTM F67. The metal bone and locking screws are made of Ti6A14V ELI that meets to ASTM F136. The materials of titanium and Ti6A14V ELI are widely used in the industry with well-known biocompatibility. No new materials are used in the development of this implant.
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