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FDA 510(k) Application Details - K191834
Device Classification Name
More FDA Info for this Device
510(K) Number
K191834
Device Name
Stand-Alone ALIF Titanium System
Applicant
Life Spine Inc.
13951 S Quality Drive
Huntley, IL 60142 US
Other 510(k) Applications for this Company
Contact
Angela Batker
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
OVD
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/09/2019
Decision Date
12/16/2019
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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