Tritium® Sternal Cable Plate System

Cerclage, Fixation

Pioneer Surgical Technology, Inc. DBA RTI Surgical, Inc.

The following data is part of a premarket notification filed by Pioneer Surgical Technology, Inc. Dba Rti Surgical, Inc. with the FDA for Tritium® Sternal Cable Plate System.

Pre-market Notification Details

• Device ID: K161876
• 510k Number: K161876
• Device Name: Tritium® Sternal Cable Plate System
• Classification: Cerclage, Fixation
• Applicant: Pioneer Surgical Technology, Inc. DBA RTI Surgical, Inc. 375 River Park Circle Marquette, MI 49855
• Contact: Sarah Pleaugh
• Correspondent: Sarah Pleaugh; Pioneer Surgical Technology, Inc. DBA RTI Surgical, Inc. 375 River Park Circle Marquette, MI 49855
• Product Code: JDQ
• Subsequent Product Code: HRS
• Subsequent Product Code: HWC
• CFR Regulation Number: 888.3010 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-07-08
• Decision Date: 2016-09-09
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00846468078164	K161876	000
00846468078157	K161876	000
00846468078140	K161876	000