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FDA 510(k) Application Details - K201500
Device Classification Name
Intervertebral Fusion Device With Bone Graft, Lumbar
More FDA Info for this Device
510(K) Number
K201500
Device Name
Intervertebral Fusion Device With Bone Graft, Lumbar
Applicant
Life Spine Inc.
13951 S Quality Drive
Huntley, IL 60142 US
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Contact
Angela Batker
Other 510(k) Applications for this Contact
Regulation Number
888.3080
More FDA Info for this Regulation Number
Classification Product Code
MAX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/05/2020
Decision Date
08/04/2020
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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