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510(k) K180078

Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF System by Innovasis, Inc. — Product Code MAX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 2018
Date Received
January 10, 2018
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.

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