Interspinous spinal fixation implant

国家: 澳大利亚

语言: 英文

来源: Department of Health (Therapeutic Goods Administration)

可用日期:

AA-Med Pty Ltd

类:

Class IIb

厂商:

Spinal Simplicity LLC 6600 College Blvd Suite 220, Overland Park, KS, 66211 United States Of America

治疗领域:

61533 - Interspinous spinal fixation implant

疗效迹象:

The Spinal Simplicity Minuteman implants are posterior, non-pedicle supplemental fixation devices, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes 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); ? Spondylolisthesis; ? Trauma (i.e., fracture or dislocation); and/or ? Tumor. The Minuteman implants are intended for use with bone graft material and is not intended for standalone use. The Minuteman implants may be implanted via a minimally invasive posterior approach (T1-S1) or a minimally invasive lateral approach (L1- S1)*. *Note: The Minuteman G3-R implant may NOT be inserted using a posterior approach.

授权状态:

A

授权日期:

2021-12-15