TRANSLACE Spinal Tethering System— 510(k) K163181

Name: FDA 510(k) clearance K163181
Creator: U.S. Food and Drug Administration
Published: 2017-05-16

Substantially Equivalent

Medtronic Sofamor Danek USA, Inc.

FDA 510(k) clearance K163181 for TRANSLACE Spinal Tethering System, Substantially Equivalent on 2017-05-16. Applicant: Medtronic Sofamor Danek USA, Inc.. Device class: 2.

Clearance details

Applicant: Medtronic Sofamor Danek USA, Inc.
Product code: Code OWI
Device class: Class 2
Regulation: 21 CFR 888.3010
Advisory panel: Orthopedic
Date received: 2016-11-14
Decision date: 2017-05-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Memphis, TN, US

Download summary PDF View on FDA.gov ↗

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