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FDA 510(k) Application Details - K213590
Device Classification Name
More FDA Info for this Device
510(K) Number
K213590
Device Name
Blue Topaz Sacroiliac Screw System
Applicant
Osseus Fusion Systems, LLC
1931 Greenville Ave, Suite 200
Dallas, TX 75206 US
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Contact
Jonathan Rosen
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Regulation Number
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Classification Product Code
OUR
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Date Received
11/12/2021
Decision Date
03/01/2022
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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