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510(k) Data Aggregation
K Number
K152324Device Name
YAHUA Spinal System
Manufacturer
BEIJING WEIGAO YAHUA ARTIFICIAL JOINT DEVELOPMENT CO. LTD.
Date Cleared
2016-02-01
(168 days)
Product Code
MNI, KWP, MNH
Regulation Number
888.3070Why did this record match?
Applicant Name (Manufacturer) :
BEIJING WEIGAO YAHUA ARTIFICIAL JOINT DEVELOPMENT CO. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The YAHUA Spinal System is intended for posterior, non-cervical, pedicle fixation for the following indications: severe spondylolisthesis (grade 3 or 4) of the L5-S1 vertebrae; trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. The device is to be used in skeletally mature patients, and for stabilization of the spine as an adjunct to fusion with bone graft. The levels of fixation are T8 - S1.
Device Description
The spinal system consists of screws, rods, crosslink plates, set screws and hooks. It is made of Titanium Alloy (Ti6Al4VELI), which meets ASTM F136-02a, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications, which are widely used for surgical implants with well-known biocompatibility. The proposed devices are provided non-sterile. It is required to be sterilized via autoclave method to reach a SAL of 106 by the hospital prior to surgery. The recommended sterilization method was validated per ISO 17665-1: 2006 Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices.
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