- Physicians Office Resource

TENSIONER 8239000 TENSIONER
TRANSLACE™ Spinal Tethering System - 8239000

Device Description

A manual, hand-held surgical instrument used during orthopaedic surgery to apply an appropriate tension to a cable that is being implanted as part of a system to provide corrective surgery for the spine. The device is typically made of high-grade stainless steel, and is designed with a low intrusion profile to minimize the surgical exposure required for tightening the cables in situ. It will also be equipped with a means for accurate and reproducible tensioning of the cable(s). This is a reusable device.

Environmental Conditions

No Data Available

Device Sizes

No Data Available

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: True

Sterilization Methods:

Moist Heat or Steam Sterilization

Moist Heat or Steam Sterilization

Product Codes

Code: OWI

Device Name: Bone Fixation Cerclage, Sublaminar

Device Class: 2

Physical State: metallic wire, polyester bands

Definition: Acts as a bone anchor for temporary stabilization, or used in conjunction with other medical implants of similar metals when wiring is needed, during development of a spinal fusion.

Submission Type ID: 1

Review Panel: OR

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Wrapped around a portion of the sublaminar, posterior spine for temporary stabilization during spinal fusion procedures. May be used in conjunction with other medical implants made of similar metals whenever wiring" may help secure the attachment of other implants.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: Y

Target Area: sublaminar, posterior spine

Regulation Number: 888.3010

Third Party Flag: N

Medical Specialty: OR

Device Identifiers

Device Id: 00763000108403

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A

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