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FDA 510(k) Application Details - K212903
Device Classification Name
More FDA Info for this Device
510(K) Number
K212903
Device Name
SIMPACT Sacroiliac Joint Fixation 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
OUR
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/13/2021
Decision Date
12/15/2021
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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