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510(k) K181995

Chiral Surgical Pedicle Screw System by Chiral Surgical — Product Code NKB

K181995 is an FDA 510(k) premarket notification submitted by Chiral Surgical for the device "Chiral Surgical Pedicle Screw System". The FDA issued a decision of Substantially Equivalent on Sep 20, 2018. 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
Sep 20, 2018
Date Received
Jul 26, 2018
Clearance Type
Traditional
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