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510(k) K211935

ORIO-Ti Intervertebral Body Fusion Cage System by Spinecraft, LLC — Product Code ODP

K211935 is an FDA 510(k) premarket notification submitted by Spinecraft, LLC for the device "ORIO-Ti Intervertebral Body Fusion Cage System". The FDA issued a decision of Substantially Equivalent on September 30, 2021. The device falls under product code ODP (Intervertebral Fusion Device With Bone Graft, Cervical), a Class II device regulated under 21 CFR 888.3080. Spinecraft, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 30, 2021
Date Received
June 22, 2021
Clearance Type
Traditional
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 Spinecraft, LLC

  • K253260 — ORIO-3D Cage System (April 16, 2026)
  • K260015 — ANTERIS Thoracolumbar Plate System (March 4, 2026)
  • K223301 — ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments (July 20, 2023)
  • K223273 — ASTRA Spine System (December 22, 2022)
  • K211323 — ASTRA Spine System (June 3, 2021)
  • K181350 — ASTRA-OCT Spine System (July 6, 2018)
  • K143683 — APEX-DL Spine System (May 22, 2015)
  • K150417 — ASTRA SPINE SYSTEM (May 19, 2015)
  • K131521 — VELOX ANTERIOR CERVICAL PLATE SYSTEM (December 24, 2013)
  • K132603 — APEX SPINE SYSTEM (November 20, 2013)

Other clearances for product code ODP

  • 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)
  • K242303 — MOD-C (April 1, 2026)
  • K252240 — Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage System (March 30, 2026)
  • K252432 — Flex-Z™ Cervical Cage (March 25, 2026)

FDA data resources