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FDA 510(k) Application Details - K020085
Device Classification Name
Orthosis, Spondyloisthesis Spinal Fixation
More FDA Info for this Device
510(K) Number
K020085
Device Name
Orthosis, Spondyloisthesis Spinal Fixation
Applicant
SINTEA BIOTECH, INC.
407 LINCOLN RD. SUITE 10L
MIAMI BEACH, FL 33139 US
Other 510(k) Applications for this Company
Contact
MARIANNE GRUNWALDT
Other 510(k) Applications for this Contact
Regulation Number
888.3070
More FDA Info for this Regulation Number
Classification Product Code
MNH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/10/2002
Decision Date
12/10/2002
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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