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FDA 510(k) Application Details - K222107
Device Classification Name
Orthosis, Cervical Pedicle Screw Spinal Fixation
More FDA Info for this Device
510(K) Number
K222107
Device Name
Orthosis, Cervical Pedicle Screw Spinal Fixation
Applicant
Osseus Fusion Systems
1931 Greenville Ave
Suite 200
Dallas, TX 75206 US
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Contact
Jonathan Rosen
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
NKG
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/18/2022
Decision Date
11/03/2022
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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