Reform Pedicle Screw System

Thoracolumbosacral Pedicle Screw System

PRECISION SPINE, INC.

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

Pre-market Notification Details

• Device ID: K143248
• 510k Number: K143248
• Device Name: Reform Pedicle Screw System
• Classification: Thoracolumbosacral Pedicle Screw System
• Applicant: PRECISION SPINE, INC. 5 SYLVAN WAY SUITE 220 Parsippany, NJ 07054
• Contact: Michael C. Dawson
• Correspondent: Kenneth C. Maxwell; EMPIRICAL CONSULTING, LLC 4628 NORTHPARK DRIVE Colorado Springs, CO 80918
• Product Code: NKB
• Subsequent Product Code: KWP
• Subsequent Product Code: MNH
• Subsequent Product Code: MNI
• Subsequent Product Code: OSH
• CFR Regulation Number: 888.3070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-11-12
• Decision Date: 2014-12-19
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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