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FDA 510(k) Application Details - K193366
Device Classification Name
Screw, Fixation, Bone
More FDA Info for this Device
510(K) Number
K193366
Device Name
Screw, Fixation, Bone
Applicant
Stryker GmbH
325 Corporate Drive
Mahwah, NJ 07430 US
Other 510(k) Applications for this Company
Contact
Cindy Leon
Other 510(k) Applications for this Contact
Regulation Number
888.3040
More FDA Info for this Regulation Number
Classification Product Code
HWC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/04/2019
Decision Date
03/20/2020
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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