Home / 510(k) Clearances / K131156

510(k) K131156

LANX SPINAL FIXATION SYSTEM by Lanx, Inc. — Product Code KWP

K131156 is an FDA 510(k) premarket notification submitted by Lanx, Inc. for the device "LANX SPINAL FIXATION SYSTEM". The FDA issued a decision of Substantially Equivalent on May 24, 2013. The device falls under product code KWP (Appliance, Fixation, Spinal Interlaminal), a Class II device regulated under 21 CFR 888.3050. Lanx, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 24, 2013
Date Received
April 24, 2013
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Spinal Interlaminal
Device Class
Class II
Regulation Number
888.3050
Review Panel
OR
Submission Type

Other clearances by Lanx, Inc.

  • K131547 — LANX FUSION SYSTEM (July 12, 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)
  • K113434 — LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS) (December 19, 2011)
  • 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 KWP

  • K143278 — LnK Posterior Cervical Fixation System (July 29, 2015)
  • K150753 — OASYS System (June 9, 2015)
  • K150851 — Sure Lok Mini Posterior Cervical/Upper Thoracic System (June 4, 2015)
  • K142867 — Reliance Posterior Cervical-Thoracic System (April 29, 2015)
  • K150254 — Streamline OCT Occipito-Cervico-Thoracic System (April 28, 2015)
  • K142253 — SOLSTICE OCT System (April 23, 2015)
  • K143249 — SOLSTICE OCT System (April 7, 2015)
  • K150229 — SOLSTICE OCT System (April 7, 2015)
  • K142741 — OASYS System (January 15, 2015)
  • K142558 — Caspian OCT/MESA Mini/DENALI Mini Spinal System (December 22, 2014)

FDA data resources