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FDA 510(k) Application Details - K221023
Device Classification Name
More FDA Info for this Device
510(K) Number
K221023
Device Name
Posterior Fusion Plate/HA Posterior Fusion Plate (Minuteman G1), Minuteman G3/HA Minuteman G3, HA Minuteman G3-R, Minuteman G5
Applicant
Spinal Simplicity LLC
6363 College Blvd, Ste 320
Overland Park, KS 66211 US
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Contact
Adam Rogers
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PEK
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More FDA Info for this Product Code
Date Received
04/06/2022
Decision Date
08/19/2022
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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