FDA 510(k)

TRANSLACE Spinal Tethering System

K-Number: K163181 · 2017-05-16

ApplicantMedtronic Sofamor Danek USA, Inc.

Decision Date2017-05-16

Product CodeOWI

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

TRANSLACE Spinal Tethering System is a medical device manufactured by Medtronic Sofamor Danek USA, Inc.. It received FDA 510(k) clearance on 2017-05-16 under approval number K163181. The device is classified under product code OWI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRANSLACE Spinal Tethering System?

TRANSLACE Spinal Tethering System is a medical device that received FDA 510(k) clearance on 2017-05-16. It is manufactured by Medtronic Sofamor Danek USA, Inc.. The 510(k) number is K163181.

When was TRANSLACE Spinal Tethering System approved by the FDA?

TRANSLACE Spinal Tethering System received FDA 510(k) clearance on 2017-05-16, under approval number K163181.

What company makes TRANSLACE Spinal Tethering System?

TRANSLACE Spinal Tethering System is manufactured by Medtronic Sofamor Danek USA, Inc..

What is the FDA product code for TRANSLACE Spinal Tethering System?

The FDA product code for TRANSLACE Spinal Tethering System is OWI.

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Other Devices by Medtronic Sofamor Danek USA, Inc.

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Related Devices (Code: OWI)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.