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510(k) K103666

LANX LATERAL by Lanx, Inc. — Product Code MAX

K103666 is an FDA 510(k) premarket notification submitted by Lanx, Inc. for the device "LANX LATERAL". The FDA issued a decision of Substantially Equivalent on March 23, 2011. The device falls under product code MAX (Intervertebral Fusion Device With Bone Graft, Lumbar), a Class II device regulated under 21 CFR 888.3080. Lanx, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 23, 2011
Date Received
December 15, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Intervertebral Fusion Device With Bone Graft, Lumbar
Device Class
Class II
Regulation Number
888.3080
Review Panel
OR
Submission Type

Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.

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)
  • 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)

Other clearances for product code MAX

  • K261049 — SCALA® TL (August 20, 2026)
  • K261430 — TruLift Expandable System (July 28, 2026)
  • K253011 — Catalyft PL Expandable Interbody System (July 17, 2026)
  • K261020 — Symmetrix™ L Spinal System (July 14, 2026)
  • K253420 — Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Space (July 1, 2026)
  • K253151 — Fule Interbody Fusion Cage System (June 15, 2026)
  • K261159 — Exceed® Biplanar Expandable Interbody System (May 29, 2026)
  • K253894 — BMD Titanium Spinal Fusion System (May 28, 2026)
  • K260506 — Ventana® P/T Lumbar Interbody System (May 15, 2026)
  • K260837 — VersaLift Expandable System (May 12, 2026)

FDA data resources