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510(k) DEN200010

Spineology Interbody Fusion System by Spineology, Inc. — Product Code OQB

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
September 18, 2020
Date Received
February 19, 2020
Clearance Type
Direct
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Intervertebral Body Graft Containment Device
Device Class
Class II
Regulation Number
888.3085
Review Panel
OR
Submission Type

An intervertebral body graft containment device is a non-rigid, implanted spinal device that is designed to contain bone graft within its internal cavity. The device is inserted into the intervertebral body space of the spine and is intended as an adjunct to intervertebral body fusion.

Other clearances by Spineology, Inc.

  • K251302 — OptiMesh Multiplanar Expandable Interbody Fusion System (December 15, 2025)
  • K251943 — Spineology Navigation Instruments (December 4, 2025)
  • K230927 — OptiMesh Multiplanar Expandable Interbody Fusion System (November 1, 2023)
  • K231781 — OptiMesh Multiplanar Expandable Interbody Fusion System (October 18, 2023)
  • K213876 — Spineology Navigation Instruments (August 5, 2022)
  • K210155 — Duo Expandable Interbody Fusion System (February 19, 2021)
  • K192047 — Rampart™ One Lumbar Interbody Fusion System (August 23, 2019)
  • K191091 — Rampart One Lumbar Interbody Fusion System (May 23, 2019)
  • K190055 — Duo Lumbar Interbody Fusion Device (March 7, 2019)
  • K182322 — Duo Lumbar Interbody Fusion Device (October 24, 2018)

Other clearances for product code OQB

  • K251302 — OptiMesh Multiplanar Expandable Interbody Fusion System (December 15, 2025)
  • K230927 — OptiMesh Multiplanar Expandable Interbody Fusion System (November 1, 2023)
  • K231781 — OptiMesh Multiplanar Expandable Interbody Fusion System (October 18, 2023)