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510(k) K200981

Mega Plus MIS Spine System by Bk Meditech, Co., Ltd. — Product Code NKB

K200981 is an FDA 510(k) premarket notification submitted by Bk Meditech, Co., Ltd. for the device "Mega Plus MIS Spine System". The FDA issued a decision of Substantially Equivalent on Aug 11, 2020. The device falls under product code NKB (Thoracolumbosacral Pedicle Screw System), 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
Aug 11, 2020
Date Received
Apr 14, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Thoracolumbosacral Pedicle Screw System
Device Class
Class II
Regulation Number
888.3070
Review Panel
OR
Submission Type
510(k)

Intended to provide immobilization and stabilization of spinal segments in thoracic, lumbar, and sacral spine as an adjunct to fusion.

Other clearances by Bk Meditech, Co., Ltd.

  • 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)
  • K090424 — DVX SPINE SYSTEM (May 14, 2009)
  • 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 NKB

  • K262091 — FRAXION Spinal Fixation System (Sep 17, 2026)
  • K262193 — RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor… (Sep 14, 2026)
  • K262828 — KHEIRON® Spinal Fixation System, including patient specific K-ROD (Sep 4, 2026)
  • K253943 — Tiger 2 System (Jul 24, 2026)
  • K260362 — QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS… (Jul 24, 2026)
  • K261284 — Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation… (Jul 14, 2026)
  • K253802 — KHEIRON® Spinal Fixation System, including patient specific K-ROD (Jul 1, 2026)
  • K253045 — “Socko” Vimax Spinal Fixation System (Jun 17, 2026)
  • K251251 — ChanPin Pedicle Screw Spinal System (Jun 9, 2026)
  • K260989 — Varion Thoracolumbar Fixation System (May 15, 2026)

FDA data resources