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510(k) K183168

OpenLoc-L Spinal Fixation System by L&K BIOMED Co., Ltd. — Product Code NKB

K183168 is an FDA 510(k) premarket notification submitted by L&K BIOMED Co., Ltd. for the device "OpenLoc-L Spinal Fixation System". The FDA issued a decision of Substantially Equivalent on Dec 11, 2018. The device falls under product code NKB (Thoracolumbosacral Pedicle Screw System), a Class II device regulated under 21 CFR 888.3070. L&K BIOMED Co., Ltd. has 57 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Dec 11, 2018
Date Received
Nov 16, 2018
Clearance Type
Special
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 L&K BIOMED Co., Ltd.

  • K262489 — BluEX Cervical Expandable Cage System (Aug 18, 2026)
  • K260840 — BluEX Cervical Expandable Cage System (May 16, 2026)
  • K261112 — CastleLoc-P Anterior Cervical Plate System (May 6, 2026)
  • K261130 — AccelFix Spinal Fixation System (May 5, 2026)
  • K260448 — CastleLoc Pectus Bar System (Mar 19, 2026)
  • K251940 — PathLoc Lumbar Plate System (Mar 3, 2026)
  • K251741 — PathLoc Lumbar Interbody Fusion Cage System (Jul 8, 2025)
  • K250892 — CastleLoc Pectus Bar System (Apr 25, 2025)
  • K243357 — CastleLoc Pectus Bar System (Feb 27, 2025)
  • K242829 — BluEX Lumbar Expandable Cage System (Oct 23, 2024)

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