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510(k) K163011

PHA S1 Spinal System by Phamedica, Inc. — Product Code NKB

K163011 is an FDA 510(k) premarket notification submitted by Phamedica, Inc. for the device "PHA S1 Spinal System". The FDA issued a decision of Substantially Equivalent on Jun 29, 2017. 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
Jun 29, 2017
Date Received
Oct 28, 2016
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