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FDA 510(k) Application Details - K003463
Device Classification Name
Orthosis, Spondyloisthesis Spinal Fixation
More FDA Info for this Device
510(K) Number
K003463
Device Name
Orthosis, Spondyloisthesis Spinal Fixation
Applicant
AESCULAP, INC.
200 GREGORY LN.
SUITE C-100
PLEASENT HILL, CA 94523-3389 US
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Contact
DAVID W SCHLERF
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
11/07/2000
Decision Date
04/11/2001
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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