SPACER 1-3212 US 12MM X STOPPK

SPACER 1
X-STOP® Interspinous Spacer - 1-3212

A device intended to be implanted between two adjacent lumbar spinous processes during a minimally-invasive procedure to decompress neural structures, typically to treat a patient with symptomatic degenerative lumbar spinal stenosis (DLSS). It is typically designed as a small spacer, either a single-piece or assembly, made of metal [e.g., titanium (Ti), nickel-titanium alloy (Nitinol)] and/or synthetic polymer [e.g., hydrogel, polyetheretherketone (PEEK)]. Disposable devices associated with implantation (e.g., introducer needles, trocars) may be included with the device.

No Data Available

• Minor Diameter 12mm

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: NQO

Device Name: Prosthesis, Spinous Process Spacer/Plate

Device Class: 3

Physical State: N/A

Definition: This device is an interspinous spacer or spinous process plate that is implanted between the spinous processes or attached to the spinous process.

Submission Type ID: 2

Review Panel: OR

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: Y

Target Area: N/A

Regulation Number: N/A

Third Party Flag: N

Medical Specialty: N/A

Device Id: 00613994598745

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