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FDA 510(k) Application Details - K201556
Device Classification Name
Screw, Fixation, Bone
More FDA Info for this Device
510(K) Number
K201556
Device Name
Screw, Fixation, Bone
Applicant
Extremity Medical, LLC.
300 Interpace Parkway, Suite 410
Parsippany, NJ 07054 US
Other 510(k) Applications for this Company
Contact
Mary Hoffman
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
06/10/2020
Decision Date
07/08/2020
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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