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FDA 510(k) Application Details - K211320
Device Classification Name
More FDA Info for this Device
510(K) Number
K211320
Device Name
CAPRI Corpectomy Cage System
Applicant
K2M, Inc.
600 Hope Parkway SE
Leesburg, VA 20175 US
Other 510(k) Applications for this Company
Contact
Renee Norby
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PLR
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/30/2021
Decision Date
02/24/2022
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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