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FDA 510(k) Application Details - K211740
Device Classification Name
Intervertebral Fusion Device With Bone Graft, Lumbar
More FDA Info for this Device
510(K) Number
K211740
Device Name
Intervertebral Fusion Device With Bone Graft, Lumbar
Applicant
Amplify Surgical, Inc.
9272 Jeronimo Rd Suite 107B
Irvine, CA 92618 US
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Contact
Andy Choi
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
06/07/2021
Decision Date
09/29/2021
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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