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

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00840019959667	K172495	000
00840019959520	K172495	000
00840019959513	K172495	000
00840019959506	K172495	000
00840019959490	K172495	000
00840019959483	K172495	000
00840019959476	K172495	000
00840019959469	K172495	000
00840019959452	K172495	000
00840019959445	K172495	000
00840019959438	K172495	000
00840019959421	K172495	000
00840019959537	K172495	000
00840019959544	K172495	000
00840019959650	K172495	000
00840019959643	K172495	000
00840019959636	K172495	000
00840019959629	K172495	000
00840019959612	K172495	000
00840019959605	K172495	000
00840019959599	K172495	000
00840019959582	K172495	000
00840019959575	K172495	000
00840019959568	K172495	000
00840019959551	K172495	000
00840019959414	K172495	000