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FDA 510(k) Application Details - K161637
Device Classification Name
Orthosis, Cervical Pedicle Screw Spinal Fixation
More FDA Info for this Device
510(K) Number
K161637
Device Name
Orthosis, Cervical Pedicle Screw Spinal Fixation
Applicant
Medyssey USA, Inc.
1550 E. Higgins Road, Suite 123
Elk Grove Village, IL 60007 US
Other 510(k) Applications for this Company
Contact
Shawn Kim
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
06/14/2016
Decision Date
01/05/2017
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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