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FDA 510(k) Application Details - K200226
Device Classification Name
Screw, Fixation, Bone
More FDA Info for this Device
510(K) Number
K200226
Device Name
Screw, Fixation, Bone
Applicant
Retrofix Screws, LLC
1035 Lincolnton Road
Salisbury, NC 28144 US
Other 510(k) Applications for this Company
Contact
Keith A Barritt
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
01/30/2020
Decision Date
06/26/2020
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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