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FDA 510(k) Application Details - K221645
Device Classification Name
Screw, Fixation, Bone
More FDA Info for this Device
510(K) Number
K221645
Device Name
Screw, Fixation, Bone
Applicant
Wright Medical Technology
1023 Cherry Road
Memphis, TN 38117 US
Other 510(k) Applications for this Company
Contact
Anna Bushart
Other 510(k) Applications for this Contact
Regulation Number
888.3040
More FDA Info for this Regulation Number
Classification Product Code
HWC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/06/2022
Decision Date
02/17/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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