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FDA 510(k) Application Details - K141694
Device Classification Name
Orthopedic Stereotaxic Instrument
More FDA Info for this Device
510(K) Number
K141694
Device Name
Orthopedic Stereotaxic Instrument
Applicant
AESCULAP IMPLANT SYSTEMS, LLC
3773 Corporate Parkway
Center Valley, PA 18034 US
Other 510(k) Applications for this Company
Contact
JULIE TOM WING
Other 510(k) Applications for this Contact
Regulation Number
882.4560
More FDA Info for this Regulation Number
Classification Product Code
OLO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/24/2014
Decision Date
02/24/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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