TETHER 9010007012 0.2MM INSERT ASSEMBLY
Translace™ Spinal Tethering System - 9010007012
Device Description
A band or cord intended to be used during surgery for the approximation, cerclage, fixation, retraction, ligation, and/or suspension of internal anatomical structures; some types may be used for connecting and supporting bone and/or ligaments and tendons. The device is typically made of a synthetic material (e.g., polyester, nylon, silicone) or cotton, is available in a variety of lengths and widths, and may be left in situ. This is a device that cannot be chemically degraded or absorbed via natural body processes. Disposable devices associated with implantation may be included. This is a single-use device.
Environmental Conditions
No Data Available
Device Sizes
- Thick
Device Sterilization
Device Sterile: True
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 IdentifiersDevice Id: 00763000333386
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