EARP INSTRUMENTS

Primary DI

00810135960649

Brand

EARP INSTRUMENTS

Company

NVision Biomedical Technologies, Inc.

Model

EARP-O

Device description

RETRACTABLE OSTEOTOME. The EARP Interbody System is intended for intervertebral body fusion in the lumbar spine in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 of the lumbosacral spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment prior to treatment with an intervertebral cage. DDD patients may also have Grade 1 spondylolisthesis or retrolisthesis at involved levels. The device system must be used with supplemental fixation and autograft to facilitate fusion and is implanted via a posterolateral approach.

Published

2023-10-18

Public version status

Update

Distribution status

In Commercial Distribution

MRI safety

Labeling does not contain MRI Safety Information

Rx

false

OTC

false

Sterile

false

Single use

false