Reform® POCT System

Posterior Cervical Screw System

Precision Spine, Inc.

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

Pre-market Notification Details

• Device ID: K172495
• 510k Number: K172495
• Device Name: Reform® POCT System
• Classification: Posterior Cervical Screw System
• Applicant: Precision Spine, Inc. 2050 Executive Drive Pearl, MS 39208
• Contact: Michael C. Dawson
• Correspondent: Meredith L. May; Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, CO 80918
• Product Code: NKG
• CFR Regulation Number: 888.3075 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-08-18
• Decision Date: 2018-04-11
• Summary: summary