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510(k) Data Aggregation
K Number
K112798Device Name
LOCKING COMPRESSION PLATE SYSTEM
Manufacturer
Date Cleared
2012-03-29
(184 days)
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
SHANGHAI MICROPORT ORTHOPEDICS CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Locking Compression Plate System can be used for adult patients with age above 21 as indicated for fixation of fractures, including ulna, radius, humerus, femur and tibia.
Device Description
The applicant device of Locking Compression Plate System consist of plates and screws, made of titanium alloy (Ti6AI4V ELI ) which meets the requirements of ASTM F136-08e1, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). The proposed devices are not provided sterile. It is required to be sterilized via autoclave method to reach a SAL of 10-6 by the hospital prior to surgery. The validated sterilization method is presented in the user manual. The plates vary through lengths and number of plate holes, and the screws vary through diameters and lengths.
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