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510(k) K192915

GMA 2.0 Pedicle Screw System by Grafton Medical Alliance — Product Code NKB

K192915 is an FDA 510(k) premarket notification submitted by Grafton Medical Alliance for the device "GMA 2.0 Pedicle Screw System". The FDA issued a decision of Substantially Equivalent on Nov 13, 2019. The device falls under product code NKB (Thoracolumbosacral Pedicle Screw System), a Class II device regulated under 21 CFR 888.3070.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Nov 13, 2019
Date Received
Oct 15, 2019
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Thoracolumbosacral Pedicle Screw System
Device Class
Class II
Regulation Number
888.3070
Review Panel
OR
Submission Type
510(k)

Intended to provide immobilization and stabilization of spinal segments in thoracic, lumbar, and sacral spine as an adjunct to fusion.

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FDA data resources