- Physicians Office Resource

TRAY 8239100 TRANSLACE INSTRUMENTS
TRANSLACE™ Spinal Tethering System - 8239100

Device Description

A container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device.

Environmental Conditions

No Data Available

Device Sizes

No Data Available

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

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: 00763000099701

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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