PCT System

Posterior Cervical Screw System

CENTINEL SPINE, INC.

The following data is part of a premarket notification filed by Centinel Spine, Inc. with the FDA for Pct System.

Pre-market Notification Details

• Device ID: K152211
• 510k Number: K152211
• Device Name: PCT System
• Classification: Posterior Cervical Screw System
• Applicant: CENTINEL SPINE, INC. 900 AIRPORT ROAD, SUITE 3B West Chester, PA 19380
• Contact: Jessica Staub
• Correspondent: Jessica Staub; CENTINEL SPINE, INC. 900 Airport Road, Suite 3B West Chester, PA 19380
• Product Code: NKG
• CFR Regulation Number: 888.3075 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-08-07
• Decision Date: 2015-12-01
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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