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FDA 510(k) Application Details - K221719
Device Classification Name
Intervertebral Fusion Device With Bone Graft, Lumbar
More FDA Info for this Device
510(K) Number
K221719
Device Name
Intervertebral Fusion Device With Bone Graft, Lumbar
Applicant
Aegis Spine, Inc.
9781 S. Meridian Blvd, Ste 300
Englewood, CO 80112 US
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Contact
KiHyang Kim
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Regulation Number
888.3080
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Classification Product Code
MAX
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More FDA Info for this Product Code
Date Received
06/13/2022
Decision Date
11/03/2022
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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