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510(k) K231781

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 2023
Date Received
June 16, 2023
Clearance Type
Special
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)
  • K213876 — Spineology Navigation Instruments (August 5, 2022)
  • K210155 — Duo Expandable Interbody Fusion System (February 19, 2021)
  • DEN200010 — Spineology Interbody Fusion System (September 18, 2020)
  • 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)
  • DEN200010 — Spineology Interbody Fusion System (September 18, 2020)