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FDA 510(k) Application Details - K231404
Device Classification Name
Fastener, Fixation, Nondegradable, Soft Tissue
More FDA Info for this Device
510(K) Number
K231404
Device Name
Fastener, Fixation, Nondegradable, Soft Tissue
Applicant
Healthium Medtech Limited
472-D, 13th Cross, 4th Phase, Peenya Industrial Area
Bangalore 560058 IN
Other 510(k) Applications for this Company
Contact
Pankaj Dawar
Other 510(k) Applications for this Contact
Regulation Number
888.3040
More FDA Info for this Regulation Number
Classification Product Code
MBI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/15/2023
Decision Date
08/04/2023
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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