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TRANSLACE™ Spinal Tethering System

FDA UDI

Class II (US FDA UDI)

by Medtronic Sofamor Danek, Inc.

Identity

Trade Name
TRANSLACE™ Spinal Tethering System FDA UDI
Generic Name
Internal spinal fixation system cable tensioner FDA UDI
Device Name
TENSIONER 8239000 TENSIONER FDA UDI
Model / Reference
8239000 FDA UDI
Description
TENSIONER 8239000 TENSIONER FDA UDI

Identifiers

Primary DI / UDI-DI
00763000675035 FDA UDI
510(k) Number
K163181 FDA UDI
FDA Product Code
OWI FDA UDI
GMDN Term
Internal spinal fixation system cable tensioner FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3010 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Internal spinal fixation system cable tensioner

TRANSLACE™ Spinal Tethering System by Medtronic Sofamor Danek, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Internal spinal fixation system cable tensioner.

Cleared under the same submission

K163181 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medtronic Sofamor Danek, Inc.

Sources (1)

  • FDA UDI c5d41bb8-26a7-4046-806b-a7b53246c7b0 35 fields · synced Jun 8, 2026