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FDA 510(k) Application Details - K111690
Device Classification Name
Orthosis, Spondyloisthesis Spinal Fixation
More FDA Info for this Device
510(K) Number
K111690
Device Name
Orthosis, Spondyloisthesis Spinal Fixation
Applicant
CHANGZHOU ORTHMED MEDICAL INSTRUMENT CO., LTD.
P.O. BOX 237-023
SHANGHAI 200237 CN
Other 510(k) Applications for this Company
Contact
Diana Hong
Other 510(k) Applications for this Contact
Regulation Number
888.3070
More FDA Info for this Regulation Number
Classification Product Code
MNH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/16/2011
Decision Date
11/22/2011
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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