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Reform® Midline Cortical Screw System — Precision Spine, Inc. (510(k) K173130)

Reform® Midline Cortical Screw System — Precision Spine, Inc. (510(k) K173130) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: Reform® Midline Cortical Screw System; Applicant: Precision Spine, Inc.; Clearance track: 510(k).

Device nameReform® Midline Cortical Screw System
ApplicantPrecision Spine, Inc.
Clearance track510(k)
Submission numberK173130
DecisionSubstantially Equivalent
Decision date2017-12-19
Date received2017-09-29
Product codeNKB
Device class2
Medical specialtyOrthopedic
Applicant locationMS, US
SourceopenFDA device

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