CONNECTOR 8205300 CONNECTOR

CONNECTOR 8205300 CONNECTOR
TRANSLACE™ Spinal Tethering System - 8205300

An implantable, small connecting component of a bone-screw internal spinal fixation system typically in the form of a thin band or small rod with a groove or hole at one or both ends, into which the screw heads and/or primary rods fit, intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, and also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. It is designed as a transverse or longitudinal connecting element to be attached to the corresponding screw heads and/or primary rods; it may also have adjustable length and/or angle and/or allow a small amount of screw/rod movement.

No Data Available

No Data Available

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

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 Id: 00643169726918

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