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510(k) K162694

Ayers Rock Cervical interbody fusion system by Spineway — Product Code ODP

K162694 is an FDA 510(k) premarket notification submitted by Spineway for the device "Ayers Rock Cervical interbody fusion system". The FDA issued a decision of Substantially Equivalent on January 12, 2017. The device falls under product code ODP (Intervertebral Fusion Device With Bone Graft, Cervical), a Class II device regulated under 21 CFR 888.3080. Spineway has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 12, 2017
Date Received
September 27, 2016
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 Spineway

  • K231658 — VEOS Spinal Fixation System (October 10, 2023)
  • K191726 — mont blanc & mont blanc MIS Spinal Systems (September 12, 2019)
  • K161387 — Mont Blanc and Mont Blanc MIS Spinal Systems (August 4, 2016)
  • K152355 — Twin Peaks Lumbar Interbody Fusion System (December 10, 2015)
  • K150185 — Mont Blanc Spinal System (May 12, 2015)
  • K150036 — Blue Mountain Cervical Plate System (May 7, 2015)

Other clearances for product code ODP

  • 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)
  • K254105 — Hive™ Standalone Cervical System and Hive™ C Interbody System (February 13, 2026)
  • K252205 — Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Inte (January 16, 2026)

FDA data resources