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510(k) K142290

KangLi pedical screw spinal system by Suzhou Kangli Orthopaedics Instrument Co., Ltd. — Product Code MNH

K142290 is an FDA 510(k) premarket notification submitted by Suzhou Kangli Orthopaedics Instrument Co., Ltd. for the device "KangLi pedical screw spinal system". The FDA issued a decision of Substantially Equivalent on November 24, 2014. The device falls under product code MNH (Orthosis, Spondylolisthesis Spinal Fixation), a Class II device regulated under 21 CFR 888.3070. Suzhou Kangli Orthopaedics Instrument Co., Ltd. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 24, 2014
Date Received
August 18, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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

  • K133840 — Kangli Locking Plate System (July 29, 2014)
  • K140053 — KANGLI PEDICLE SCREW SPINAL SYSTEM (June 26, 2014)

Other clearances for product code MNH

  • K162066 — Reliance Spinal Screw System (December 2, 2016)
  • K162801 — CastleLoc Spinal Fixation System (November 3, 2016)
  • K162143 — FixxSure® X-Link (September 23, 2016)
  • K161151 — Spinal fixation system (September 21, 2016)
  • K162189 — ANAX™ 5.5 Spinal System (August 30, 2016)
  • K151362 — HC Spinal System (May 5, 2016)
  • K153404 — Zavation Spinal System (April 21, 2016)
  • K160020 — Captiva Spine and CapLOX II/TowerLOX Pedicle Screw System (March 2, 2016)
  • K143013 — Spinal Inner Fixation System (December 11, 2015)
  • K151695 — Romeo posterior osteosynthesis system (September 10, 2015)

FDA data resources