Home / 510(k) Clearances / K142392

510(k) K142392

Zavation Posterior LEIF by Zavation, LLC — Product Code MAX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 2015
Date Received
August 27, 2014
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 Zavation, LLC

  • K162206 — Zavation IBF (April 4, 2017)
  • K162575 — Z-LINKPC System (March 3, 2017)
  • K162824 — Z-Span Plate System (February 17, 2017)
  • K161016 — Z-Clamp ISP System (October 19, 2016)
  • K153404 — Zavation Spinal System (April 21, 2016)
  • K160362 — Z-Span Plate System (March 22, 2016)
  • K142271 — Zavation Z-Link Lumbar (December 19, 2014)
  • K141419 — ZVPLASTY (September 12, 2014)
  • K141005 — Z-LINK CERVICAL (August 7, 2014)
  • K130030 — ZAVATION CERVICAL PLATE SYSTEM (April 25, 2013)

Other clearances for product code MAX

  • K254017 — SWINGO-3D Lumbar Cage System (February 26, 2026)
  • K253583 — LUX Expandable Lumbar Interbody System (February 23, 2026)
  • K250773 — Luna® Ti Interbody Fusion System (February 4, 2026)
  • K253748 — Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spac (January 23, 2026)
  • K253266 — Titanium Interbody System (January 8, 2026)
  • K253577 — IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter) (December 19, 2025)
  • K252610 — ZSFab Lumbar Interbody System (November 25, 2025)
  • K252351 — UniSpace® TPLIF Cage (October 28, 2025)
  • K253377 — Expandable Titanium PLIF/TLIF System (October 24, 2025)
  • K251479 — Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion C (September 18, 2025)