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FDA 510(k) Application Details - K162341
Device Classification Name
Orthopedic Stereotaxic Instrument
More FDA Info for this Device
510(K) Number
K162341
Device Name
Orthopedic Stereotaxic Instrument
Applicant
Stryker Leibinger GmbH & Co. KG
Boetzinger Strasse 41
Freiburg D-79111 DE
Other 510(k) Applications for this Company
Contact
N/A N/A
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
08/22/2016
Decision Date
10/12/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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