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510(k) K113434

LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS) by Lanx, Inc. — Product Code NKB

K113434 is an FDA 510(k) premarket notification submitted by Lanx, Inc. for the device "LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS)". The FDA issued a decision of Substantially Equivalent on December 19, 2011. The device falls under product code NKB (Thoracolumbosacral Pedicle Screw System), a Class II device regulated under 21 CFR 888.3070. Lanx, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 2011
Date Received
November 21, 2011
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

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

Other clearances by Lanx, Inc.

  • K131547 — LANX FUSION SYSTEM (July 12, 2013)
  • K131156 — LANX SPINAL FIXATION SYSTEM (May 24, 2013)
  • K123767 — LANX FUSION SYSTEM- SA (March 18, 2013)
  • K121316 — LANX SPINAL FIZATION SYSTEM (September 10, 2012)
  • K122145 — LANX SPINAL FIXATION SYSTEM (August 17, 2012)
  • K121940 — LANX SPINAL FIXATION SYSTEM (August 2, 2012)
  • K120399 — LANX SPINAL FIXATION SYSTEM (March 9, 2012)
  • K112388 — LANX CERVICAL SA (December 16, 2011)
  • K103091 — LANX SPINAL FIXATION SYSTEM (April 15, 2011)
  • K103237 — LANX SPINAL SYSTEM (March 25, 2011)

Other clearances for product code NKB

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

FDA data resources