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FDA 510(k) Application Details - K192434
Device Classification Name
Intervertebral Fusion Device With Bone Graft, Lumbar
More FDA Info for this Device
510(K) Number
K192434
Device Name
Intervertebral Fusion Device With Bone Graft, Lumbar
Applicant
Amplify Surgical Inc
27071 Cabot Road, Suite 118
Laguna Hills, CA 82653 US
Other 510(k) Applications for this Company
Contact
Andy Choi
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
09/05/2019
Decision Date
10/15/2019
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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