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FDA 510(k) Application Details - K221936
Device Classification Name
More FDA Info for this Device
510(K) Number
K221936
Device Name
Standalone ALIF Interbody Fusion System
Applicant
Eminent Spine
2004 Ventura Drive
Suite 100
Plano, TX 75093 US
Other 510(k) Applications for this Company
Contact
Stephen Courtney
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
OVD
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/01/2022
Decision Date
10/17/2022
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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