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510(k) K190067

Velofix Interbody Fusion System by U&I Corporation — Product Code ODP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 2019
Date Received
January 15, 2019
Clearance Type
Special
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.

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