Reform Pedicle Screw System

Thoracolumbosacral Pedicle Screw System

Precision Spine

The following data is part of a premarket notification filed by Precision Spine with the FDA for Reform Pedicle Screw System.

Pre-market Notification Details

• Device ID: K200303
• 510k Number: K200303
• Device Name: Reform Pedicle Screw System
• Classification: Thoracolumbosacral Pedicle Screw System
• Applicant: Precision Spine 2050 Executive Drive Pearl, MS 39208
• Contact: Micheal C. Dawson
• Correspondent: John D. Webb; The OrthoMedix Group, Inc. 4313 W. 3800 S. West Haven, UT 84401
• Product Code: NKB
• CFR Regulation Number: 888.3070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-02-06
• Decision Date: 2020-05-19

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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