SPINOUS PROCESS FIXATION PLATE

SPINOUS PROCESS FIXATION PLATE
UniVise - 48590035

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

• Length: 35.0 Millimeter

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: PEK

Device Name: Spinous Process Plate

Device Class: 2

Physical State: Plates with teeth/spikes and crossbar/tray/bumper that connects and locks plates together, metallic, metallic and polymer combination

Definition: A posterior, non-pedicle supplemental fixation device intended for single level use in the non-cervical spine (T1-S1). It is intended for single level plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: Degenerative Disc Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), Trauma (i.e., fracture or dislocation), Spondylolisthesis, and/or Tumor. It is not intended for stand-alone use.

Submission Type ID: 1

Review Panel: OR

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Placed between two spinous processes to immobilize the segment, provide supplemental stabilization, and to facilitate fusion at the treated level

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: Y

Target Area: Non-cervical spine (T1-S1)

Regulation Number: 888.3050

Third Party Flag: N

Medical Specialty: OR

Code: KWP

Device Name: Appliance, Fixation, Spinal Interlaminal

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

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: 888.3050

Third Party Flag: N

Medical Specialty: OR

Device Id: 07613327065640

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