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510(k) K151592

Gemmed pedicle screw spinal system by Suzhou Gemmed Medical Instrument Co., Ltd. — Product Code MNI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 24, 2015
Date Received
June 12, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthosis, Spinal Pedicle Fixation
Device Class
Class II
Regulation Number
888.3070
Review Panel
OR
Submission Type

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