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510(k) K190291

Addivation Medical Cervical Interbody System by Addivation Medical, LLC — Product Code ODP

K190291 is an FDA 510(k) premarket notification submitted by Addivation Medical, LLC for the device "Addivation Medical Cervical Interbody System". The FDA issued a decision of Substantially Equivalent on Jul 30, 2019. The device falls under product code ODP (Intervertebral Fusion Device With Bone Graft, Cervical), a Class II device regulated under 21 CFR 888.3080.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jul 30, 2019
Date Received
Feb 11, 2019
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
510(k)

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

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  • K254130 — C.A. Medical Interbody Fusion System (Jul 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 (Apr 24, 2026)
  • K253260 — ORIO-3D Cage System (Apr 16, 2026)
  • K260340 — HC BIOLOGICS OSTEOPOINT PEEK CAGES, HC BIOLOGICS OSTEOPOINT CERVICAL PEEK CAGES… (Apr 13, 2026)

FDA data resources