TRANSLACE™ Spinal Tethering System

Bone Fixation Cerclage, Sublaminar

Medtronic Sofamor Danek USA, Inc.

The following data is part of a premarket notification filed by Medtronic Sofamor Danek Usa, Inc. with the FDA for Translace™ Spinal Tethering System.

Pre-market Notification Details

• Device ID: K163181
• 510k Number: K163181
• Device Name: TRANSLACE™ Spinal Tethering System
• Classification: Bone Fixation Cerclage, Sublaminar
• Applicant: Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Place Memphis, TN 38132
• Contact: Becky Ronner
• Correspondent: Claire Evans; Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Place Memphis, TN 38132
• Product Code: OWI
• CFR Regulation Number: 888.3010 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-11-14
• Decision Date: 2017-05-16
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00643169742949	K163181	000
00763000108403	K163181	000
00763000333386	K163181	000
00763000333393	K163181	000
00763000333409	K163181	000
00763000099701	K163181	000
00763000108380	K163181	000
00763000108397	K163181	000
00643169726918	K163181	000
00643169726925	K163181	000
00643169726932	K163181	000
00763000675035	K163181	000