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510(k) K161404

Genesys Spine Apache® Lateral Lumbar Interbody Fusion System by Genesys Spine — Product Code MAX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 21, 2016
Date Received
May 20, 2016
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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