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FDA 510(k) Application Details - K193174
Device Classification Name
Intervertebral Fusion Device With Bone Graft, Lumbar
More FDA Info for this Device
510(K) Number
K193174
Device Name
Intervertebral Fusion Device With Bone Graft, Lumbar
Applicant
Keos
1824 Colonial Village Lane
Lancaster, PA 17601 US
Other 510(k) Applications for this Company
Contact
Scott Peterson
Other 510(k) Applications for this Contact
Regulation Number
888.3080
More FDA Info for this Regulation Number
Classification Product Code
MAX
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More FDA Info for this Product Code
Date Received
11/18/2019
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
Special
Reviewed By Third Party
N
Expedited Review
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