510(k) K131547

LANX FUSION SYSTEM by Lanx, Inc. — Product Code OVD

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: July 12, 2013
Date Received: May 29, 2013
Clearance Type: Special
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Intervertebral Fusion Device With Integrated Fixation, Lumbar
Device Class: Class II
Regulation Number: 888.3080
Review Panel: OR
Submission Type

Intended to stabilize lumbar spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.

Other clearances by Lanx, Inc.

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)
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 OVD

K253559 — Ventana A Anterior Lumbar Interbody System (February 25, 2026)
K251829 — DeGen Medical Patient Specific Implant (PSI) System (December 8, 2025)
K251575 — IdentiTi II ALIF Standalone Interbody System; Transcend ALIF Standalone Interb (September 3, 2025)
K250072 — CONDUIT SYNFIX Evolution Secured Spacer System (July 10, 2025)
K251644 — ProAM ALIF System (June 24, 2025)
K250845 — Curiteva Porous PEEK Standalone ALIF System (June 18, 2025)
K251459 — OneLIF Interbody Fusion System (June 12, 2025)
K243934 — Stable-L Lumbar Interbody System (April 30, 2025)
K243386 — Ventris Intervertebral Body Fusion Device (April 22, 2025)
K250603 — AxTiHA® Stand-Alone ALIF System (March 24, 2025)