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510(k) Data Aggregation
K Number
K191803Device Name
Orthopedic Fixation Pin
Manufacturer
Tinavi (Anhui) Medical Technologies Co., Ltd.
Date Cleared
2020-04-14
(286 days)
Product Code
JDW
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
Tinavi (Anhui) Medical Technologies Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Orthopedic Fixation Pin is indicated for fixation of bone fractures, bone reconstruction, and as guide pins for insertion of other implants.
Device Description
The Orthopedic Fixation Pin is straight, partially threaded; and has trocar point on one end. The device is available in various diameters and lengths to accommodate the specific indication. The pins are made from stainless steel in accordance with ASTM F138-13.
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