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510(k) K090424

DVX SPINE SYSTEM by Bk Meditech, Co., Ltd. — Product Code MNH

K090424 is an FDA 510(k) premarket notification submitted by Bk Meditech, Co., Ltd. for the device "DVX SPINE SYSTEM". The FDA issued a decision of Substantially Equivalent on May 14, 2009. The device falls under product code MNH (Orthosis, Spondylolisthesis Spinal Fixation), a Class II device regulated under 21 CFR 888.3070. Bk Meditech, Co., Ltd. has 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 2009
Date Received
Feb 19, 2009
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
510(k)

Other clearances by Bk Meditech, Co., Ltd.

  • K200981 — Mega Plus MIS Spine System (Aug 11, 2020)
  • K183080 — Mega Plus Spine System (Dec 10, 2018)
  • K173180 — Mega Plus Spine System (Mar 15, 2018)
  • K140577 — INNESIS PEEK TL CAGE (Oct 1, 2014)
  • K132483 — INNESIS PEEK CERVICAL CAGE (Apr 2, 2014)
  • K120464 — INNESIS PEEK CAGE (Jan 18, 2013)
  • K110426 — DYNA-EXTOR II (Nov 2, 2011)
  • K080876 — DVX SPINE SYSTEM (Jun 4, 2008)
  • K072436 — MEGA SPINE SYSTEM (Nov 1, 2007)
  • K061599 — PIN SCREW (Jul 26, 2006)

Other clearances for product code MNH

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

FDA data resources