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FDA 510(k) Application Details - K222082
Device Classification Name
Intervertebral Fusion Device With Bone Graft, Lumbar
More FDA Info for this Device
510(K) Number
K222082
Device Name
Intervertebral Fusion Device With Bone Graft, Lumbar
Applicant
Carlsmed, Inc.
1800 Aston Ave., Ste 100
Carlsbad, CA 92008 US
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Contact
Karen Liu
Other 510(k) Applications for this Contact
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
07/15/2022
Decision Date
08/12/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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