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FDA 510(k) Application Details - K223226
Device Classification Name
More FDA Info for this Device
510(K) Number
K223226
Device Name
TrigonÖ HA Stand-Alone Wedge Fixation System
Applicant
Nvision Biomedical Technologies, Inc.
4590 Lockhill Selma
San Antonio, TX 78249 US
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Contact
Diana Langham
Other 510(k) Applications for this Contact
Regulation Number
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Classification Product Code
PLF
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More FDA Info for this Product Code
Date Received
10/18/2022
Decision Date
12/01/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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