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FDA 510(k) Application Details - K191803
Device Classification Name
Pin, Fixation, Threaded
More FDA Info for this Device
510(K) Number
K191803
Device Name
Pin, Fixation, Threaded
Applicant
Tinavi (Anhui) Medical Technologies Co., Ltd.
Building 5,Robot Industrial Base of TusCity,
Jinxiu Avenue/Susong Road,
Hefei 230601 CN
Other 510(k) Applications for this Company
Contact
Jianhua Jiang
Other 510(k) Applications for this Contact
Regulation Number
888.3040
More FDA Info for this Regulation Number
Classification Product Code
JDW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/03/2019
Decision Date
04/14/2020
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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