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510(k) K201614

TxTiHA IBF System, AxTiHA Stand-Alone ALIF System by Innovasis, Inc. — Product Code MAX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 15, 2020
Date Received
June 15, 2020
Clearance Type
Special
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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