Search Results
Found 1 results
510(k) Data Aggregation
K Number
K130066Device Name
SPECTRUM SPINE SPINOUS PROCESS DEVICE
Manufacturer
Date Cleared
2013-11-12
(306 days)
Product Code
Regulation Number
888.3050Why did this record match?
Applicant Name (Manufacturer) :
SPECTRUM SPINE IP HOLDINGS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Spectrum SPINOUS PROCESS DEVICE is a posterior, non-pedicle supplemental fixation device, intended for use at a single-level in the non-cervical spine (T1-S1 inclusive). It is intended for plate fixation and attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain or discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation), and/or tumor. The Spectrum Spine SPINOUS PROCESS DEVICE is intended for use with bone graft, and is not intended for standalone use.
Device Description
The Spectrum Spine Spinous Process Device is a permanent implant device with plates and rods made from Titanium Alloy per ASTM F136 and Commercially Pure Titanium per ASTM F67 and cages made from polyetheretherketone (Zeniva PEEK 500 per ASTM F2026-10, PEEK Polymer for surgical implant applications). It is a posterior, non-pedicle supplemental fixation device. The device provides plates, cages and connecting rods of various shapes and sizes to provide supplemental stabilization of the spinous process to support fusion.
Ask a Question
Ask a specific question about this device
Page 1 of 1