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FDA 510(k) Application Details - K192428
Device Classification Name
Fastener, Fixation, Nondegradable, Soft Tissue
More FDA Info for this Device
510(K) Number
K192428
Device Name
Fastener, Fixation, Nondegradable, Soft Tissue
Applicant
Cayenne Medical
16597 N 92nd Street
Scottsdale, AZ 85260 US
Other 510(k) Applications for this Company
Contact
Shima Hashemian
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
09/05/2019
Decision Date
10/05/2019
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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