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510(k) K134011

GENERAL SPINAL SYSTEM by Changzhou Dean Medical Instrument Co, Ltd. — Product Code MNH

K134011 is an FDA 510(k) premarket notification submitted by Changzhou Dean Medical Instrument Co, Ltd. for the device "GENERAL SPINAL SYSTEM". The FDA issued a decision of Substantially Equivalent on September 3, 2014. The device falls under product code MNH (Orthosis, Spondylolisthesis Spinal Fixation), a Class II device regulated under 21 CFR 888.3070. Changzhou Dean Medical Instrument Co, Ltd. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 3, 2014
Date Received
December 30, 2013
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 Changzhou Dean Medical Instrument Co, Ltd.

  • K133525 — LOCKING COMPRESSION BONE PLATES AND SCREW SYSTEM (March 4, 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