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510(k) K191927

Hinged Laminoplasty System by Life Spine, Inc. — Product Code NQW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 2019
Date Received
July 19, 2019
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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