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510(k) Data Aggregation
K Number
K132642Device Name
LOCKING PLATE SYSTEM
Manufacturer
BEIJING LIBEIER BIO-ENGINEERING INSTITUTE CO., LTD
Date Cleared
2013-10-03
(38 days)
Product Code
HRS, HWC
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
BEIJING LIBEIER BIO-ENGINEERING INSTITUTE CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Locking Plate System can be used for adult patients with age above 21 as indicated for fixation of fractures, including ulna, radius, humerus, femur tibia and fibula.
Device Description
The proposed products, Locking Plate System, contain (1) locking plates (1.Ps) with various specifications. (2) locking screws with various specifications and (3) various specific instruments. Locking Plates are the plates that made of Titanium. The limited-contact design of LPs reduces plate-to-bone contact, thus limiting vascular trauma. The screws are available in three kinds, which are 3.5mm Hexagonal Locking Screws with hexagonal interface, 3.5mm Stardrive Locking Screws with Torx interface, and 5.0mm Locking Screws with hexagonal interface. There are various instruments specific to the proposed device intend for completing the surgery.
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