Home / 510(k) Clearances / K210521

510(k) K210521

DEXA-C Cervical Interbody System by Aurora Spine, Inc. — Product Code ODP

K210521 is an FDA 510(k) premarket notification submitted by Aurora Spine, Inc. for the device "DEXA-C Cervical Interbody System". The FDA issued a decision of Substantially Equivalent on August 2, 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. Aurora Spine, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 2021
Date Received
February 23, 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 Aurora Spine, Inc.

  • K243865 — AERO MIS Facet Fusion System (March 24, 2025)
  • K221047 — SILO TFX MIS Sacroiliac Joint Fixation System (October 3, 2022)
  • K221399 — ZIP™ MIS Interspinous Fusion System (July 8, 2022)
  • K220610 — SOLO-L (May 27, 2022)
  • K210325 — APOLLO Anterior Cervical Plate (ACP) System (March 23, 2021)
  • K141317 — ZIP MIS INTERSPINOUS FUSION SYSTEM (November 17, 2014)
  • K140715 — ZIP MIS INTERSPINOUS FUSION SYSTEM (April 17, 2014)
  • K133967 — INTERBODY CAGE SYSTEM (January 31, 2014)
  • K133091 — ZIP MIS INTERSPINOUS FUSION SYSTEM (November 27, 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