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510(k) K113559

LDR SPINE CERVICAL INTERBODY FUSION SYSTME-ROI-C LORDOTIC IMPLANTS by Ldr Spine USA, Inc. — Product Code ODP

K113559 is an FDA 510(k) premarket notification submitted by Ldr Spine USA, Inc. for the device "LDR SPINE CERVICAL INTERBODY FUSION SYSTME-ROI-C LORDOTIC IMPLANTS". The FDA issued a decision of Substantially Equivalent on December 29, 2011. The device falls under product code ODP (Intervertebral Fusion Device With Bone Graft, Cervical), a Class II device regulated under 21 CFR 888.3080. Ldr Spine USA, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 29, 2011
Date Received
December 1, 2011
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

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

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

Other clearances by Ldr Spine USA, Inc.

  • 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 ODP

  • K262595 — VariLift-C Cervical Interbody Fusion System (August 26, 2026)
  • K262489 — BluEX Cervical Expandable Cage System (August 18, 2026)
  • K253041 — 3d Cage Cervical (July 23, 2026)
  • K262061 — Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Po (July 17, 2026)
  • K254130 — C.A. Medical Interbody Fusion System (July 8, 2026)
  • K260840 — BluEX Cervical Expandable Cage System (May 16, 2026)
  • K260850 — OSTEOMNI SPINAL CAGES SYSTEM (May 12, 2026)
  • K260549 — ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System (April 24, 2026)
  • K253260 — ORIO-3D Cage System (April 16, 2026)
  • K260340 — HC BIOLOGICS OSTEOPOINT PEEK CAGES, HC BIOLOGICS OSTEOPOINT CERVICAL PEEK CAGES, (April 13, 2026)

FDA data resources