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510(k) K212701

Eminent Spine 3D Cervical Interbody Fusion System by Eminent Spine — Product Code ODP

K212701 is an FDA 510(k) premarket notification submitted by Eminent Spine for the device "Eminent Spine 3D Cervical Interbody Fusion System". The FDA issued a decision of Substantially Equivalent on February 6, 2023. The device falls under product code ODP (Intervertebral Fusion Device With Bone Graft, Cervical), a Class II device regulated under 21 CFR 888.3080. Eminent Spine has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 6, 2023
Date Received
August 25, 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 Eminent Spine

  • K250894 — Eminent Spine Posterior SI System (October 7, 2025)
  • K241663 — Eminent Spine 3D Titanium Pedicle Screw System (April 28, 2025)
  • K242069 — Eminent Spine Scoliosis Deformity Pedicle Screw System (September 3, 2024)
  • K240505 — Eminent Spine SI Screw System (June 4, 2024)
  • K230219 — Eminent Spine 3D Lumbar Interbody Fusion Systems (May 16, 2023)
  • K221936 — Standalone ALIF Interbody Fusion System (October 17, 2022)
  • K212853 — Cervical Stand-Alone System (November 5, 2021)
  • K201979 — Cervical Plate System (August 25, 2020)
  • K143365 — Eminent Foot Plate System (March 30, 2015)
  • K133194 — DIAMOND RATTLESNAKE SYSTEM (June 26, 2014)

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