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510(k) K190363

Omnia Medical TiBrid Cervical Cage, Omnia Medical TiBrid Lateral Cage, Omnia Medical TiBrid ALIF Cage, Omnia Medical TiBrid PLIF Cage, Omnia Medical TiBrid TLIF Cage by Omnia Medical, LLC — Product Code MAX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 2020
Date Received
February 15, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Intervertebral Fusion Device With Bone Graft, Lumbar
Device Class
Class II
Regulation Number
888.3080
Review Panel
OR
Submission Type

Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.

Other clearances by Omnia Medical, LLC

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  • K223321 — Omnia Medical Coupler-C Anterior Cervical Plate (March 13, 2023)
  • K212612 — Omnia Medical TiBrid-SC (November 15, 2022)
  • K203207 — Omnia Medical TiBrid-SA (December 23, 2020)
  • K192096 — Omnia Medical Trauma Screws (February 27, 2020)
  • K191778 — Omnia Medical VBR (August 28, 2019)
  • K183659 — Omnia Medical Rotary PLIF System (February 6, 2019)
  • K172323 — Omnia Medical VBR (October 26, 2017)

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  • K252351 — UniSpace® TPLIF Cage (October 28, 2025)
  • K253377 — Expandable Titanium PLIF/TLIF System (October 24, 2025)
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