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510(k) K162133

VerteFIT Corpectomy Cage System by Ldr Spine USA, Inc. — Product Code MQP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 16, 2017
Date Received
August 1, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spinal Vertebral Body Replacement Device
Device Class
Class II
Regulation Number
888.3060
Review Panel
OR
Submission Type

Other clearances by Ldr Spine USA, Inc.

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  • K161798 — FacetBRIDGE® System (August 4, 2016)
  • K153495 — Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, (March 31, 2016)
  • K152137 — FacetBRIDGE System (January 25, 2016)
  • K151934 — ROI-C Titanium-Coated Implant System (December 7, 2015)
  • K150765 — LDR Spine ROI-C Cervical Cage System (September 17, 2015)
  • K142645 — Avenue T TLIF Cage (June 11, 2015)
  • K133363 — INTERBRIDGE INTERSPINOUS POSTERIOR FIXATION SYSTEM (March 7, 2014)
  • K123134 — EASYSPINE SYSTEM (February 1, 2013)
  • K121103 — LDR SPINE USA SPINE TUNE, TL SPINAL SYSTEM, LDR SPINE USA EASYSPINE, POSTERIOR S (August 24, 2012)

Other clearances for product code MQP

  • K253158 — VyBrate™ VBR System (January 7, 2026)
  • K241468 — Vertiwedge® Intraosseous System (November 7, 2024)
  • K232790 — KONG®-TL VBR System and KONG® C VBR System (April 4, 2024)
  • K233359 — DOMINION Expandable Corpectomy System (March 8, 2024)
  • K231134 — VerteLoc Spinal System (February 13, 2024)
  • K232173 — Ascend VBR System, Ascend NanoTec VBR System (October 6, 2023)
  • K211892 — ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages) (October 6, 2022)
  • K202637 — F3D Corpectomy System (December 23, 2020)
  • K200235 — KONG-TL VBR System, KONG-C VBR System (May 29, 2020)
  • K193506 — NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable (February 26, 2020)