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FDA 510(k) Application Details - K210239
Device Classification Name
Fastener, Fixation, Biodegradable, Soft Tissue
More FDA Info for this Device
510(K) Number
K210239
Device Name
Fastener, Fixation, Biodegradable, Soft Tissue
Applicant
Acuitive Technologies, Inc.
50 Commerce Drive
Allendale, NJ 07401 US
Other 510(k) Applications for this Company
Contact
Matthew Poggie
Other 510(k) Applications for this Contact
Regulation Number
888.3030
More FDA Info for this Regulation Number
Classification Product Code
MAI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/29/2021
Decision Date
02/24/2021
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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