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FDA 510(k) Application Details - K221947
Device Classification Name
Staple, Fixation, Bone
More FDA Info for this Device
510(K) Number
K221947
Device Name
Staple, Fixation, Bone
Applicant
Tyber Medical, LLC.
83 South Commerce Way
Suite 310
Bethlehem, PA 18017 US
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Contact
Lisa Boyle
Other 510(k) Applications for this Contact
Regulation Number
888.3030
More FDA Info for this Regulation Number
Classification Product Code
JDR
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/05/2022
Decision Date
10/20/2022
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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