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510(k) K202302

Atlas Spine Rebar (Ti) Spacer System by Atlas Spine, Inc. — Product Code ODP

K202302 is an FDA 510(k) premarket notification submitted by Atlas Spine, Inc. for the device "Atlas Spine Rebar (Ti) Spacer System". The FDA issued a decision of Substantially Equivalent on October 30, 2020. The device falls under product code ODP (Intervertebral Fusion Device With Bone Graft, Cervical), a Class II device regulated under 21 CFR 888.3080. Atlas Spine, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 2020
Date Received
August 14, 2020
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 Atlas Spine, Inc.

  • K252822 — Atlas Spine HiRISE™ Expandable Cervical-p Corpectomy Implant (July 15, 2026)
  • K252560 — Atlas Spine HiRISE™ Expandable Cervical Corpectomy System (November 10, 2025)
  • K251969 — Atlas Spine Project X Expandable Posterior Lumbar Interbody System (August 15, 2025)
  • K243191 — Atlas Spine Lateral Expandable Interbody System (November 26, 2024)
  • K192570 — Atlas Spine Expandable Cervical Standalone Interbody System (February 28, 2020)
  • K182418 — V3 Segmental Plating System (November 29, 2018)
  • K180675 — Atlas Spine Expandable Cervical Interbody System (June 13, 2018)
  • K172334 — Ortus™ Expandable Lumbar Interbody Fusion System (October 25, 2017)
  • K162918 — Atlas Spine Expandable Interbody System (February 9, 2017)
  • K112759 — APCLO PEDICLE SCREW SYSTEMS (October 18, 2011)

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