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FDA 510(k) Application Details - K211628
Device Classification Name
Screw, Fixation, Bone
More FDA Info for this Device
510(K) Number
K211628
Device Name
Screw, Fixation, Bone
Applicant
RELJA Innovations, LLC
17145 W. Bluemound Rd., Suite #J-265
Brookfield, WI 53005 US
Other 510(k) Applications for this Company
Contact
David Pancratz
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
05/27/2021
Decision Date
01/31/2022
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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