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510(k) K153495

Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T Implant System by Ldr Spine USA — Product Code MAX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 2016
Date Received
December 7, 2015
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 Ldr Spine USA

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  • 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)

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