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510(k) K133840

Kangli Locking Plate System by Suzhou Kangli Orthopaedics Instrument Co., Ltd. — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 29, 2014
Date Received
December 18, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Fixation, Bone
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

Other clearances by Suzhou Kangli Orthopaedics Instrument Co., Ltd.

  • K142290 — KangLi pedical screw spinal system (November 24, 2014)
  • K140053 — KANGLI PEDICLE SCREW SPINAL SYSTEM (June 26, 2014)

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