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FDA 510(k) Application Details - K192645
Device Classification Name
More FDA Info for this Device
510(K) Number
K192645
Device Name
TrigonÖ Ti Stand-Alone Wedge Fixation System
Applicant
Nvision Biomedical Technologies, Inc.
4754 Shavano Oak, Suite 101
San Antonio, TX 78249 US
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Contact
Diana Langham
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PLF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/24/2019
Decision Date
12/23/2019
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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