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510(k) K110327

LDR SPINE ROI-A INTERBODY FUSION SYSTEM by Ldr Spine USA — Product Code OVD

K110327 is an FDA 510(k) premarket notification submitted by Ldr Spine USA for the device "LDR SPINE ROI-A INTERBODY FUSION SYSTEM". The FDA issued a decision of Substantially Equivalent on September 30, 2011. The device falls under product code OVD (Intervertebral Fusion Device With Integrated Fixation, Lumbar), a Class II device regulated under 21 CFR 888.3080. Ldr Spine USA has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 30, 2011
Date Received
February 3, 2011
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 Ldr Spine USA

  • K162133 — VerteFIT Corpectomy Cage System (May 16, 2017)
  • K161173 — Avenue® T TLIF Cage (September 28, 2016)
  • 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)

Other clearances for product code OVD

  • K262025 — Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis (September 11, 2026)
  • K261408 — SABER-XA System (August 3, 2026)
  • K261809 — Interwedge® Standalone Lateral (July 31, 2026)
  • K261353 — Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lum (July 15, 2026)
  • K260810 — Anteralign LS coverplate (June 10, 2026)
  • K254202 — MectaLIF 3D Metal Anterior (May 5, 2026)
  • K253401 — SCRIPT™ Implant System (April 29, 2026)
  • 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)

FDA data resources