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FDA 510(k) Application Details - K221050
Device Classification Name
More FDA Info for this Device
510(K) Number
K221050
Device Name
ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior Cervical Plate System, Spinema Lumbar Plate System
Applicant
Aegis Spine, Inc.
9781 S. Meridian Blvd, Ste 300
Englewood, CO 80112 US
Other 510(k) Applications for this Company
Contact
Kihyang Kim
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
OUR
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/11/2022
Decision Date
06/30/2022
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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