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510(k) K160114

Xspan Laminoplasty Fixation System by X-Spine Systems, Inc. — Product Code NQW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 2016
Date Received
January 19, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthosis, Spine, Plate, Laminoplasty, Metal
Device Class
Class II
Regulation Number
888.3050
Review Panel
OR
Submission Type

This device is a plate that is attached to the lamina after a laminoplasty or laminectomy procedure.

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  • K160959 — Xsert Lumbar Expandable Interbody System (November 17, 2016)
  • K162944 — Irix-C Cervical Integrated Fusion System (November 7, 2016)
  • K160428 — Certex Spinal Fixation System (May 5, 2016)

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