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EARP FINAL INSERTER. 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.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
EARP-FI
In Commercial Distribution
- 00810135960632 ()
- General internal orthopaedic fixation system implantation kit
EARP INITIAL INSERTER. 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.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
EARP-II
In Commercial Distribution
- 00810135960625 ()
- General internal orthopaedic fixation system implantation kit
EARP DISC SPACER INSERTER. 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.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
EARP-DS-002
In Commercial Distribution
- 00810135960618 ()
- General internal orthopaedic fixation system implantation kit
EARP DISC SPACER 14MM 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.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
EARP-DS-001-14
In Commercial Distribution
- 00810135960601 ()
- General internal orthopaedic fixation system implantation kit
EARP DISC SPACER 10MM 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.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
EARP-DS-001-10
In Commercial Distribution
- 00810135960588 ()
- General internal orthopaedic fixation system implantation kit
Retropsoas Electrode, NERVE CUFF TRIAL SIZER, 8/10MM. The EARP Nerve Cuff Electrode is used to perform localized stimulation of neural tissue and to locate, identify, and monitor spinal nerve roots during surgery.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
ELEC2280
In Commercial Distribution
- 00810135960564 ()
- General internal orthopaedic fixation system implantation kit
Retropsoas Electrode, NERVE CUFF APPLICATOR. The EARP Nerve Cuff Electrode is used to perform localized stimulation of neural tissue and to locate, identify, and monitor spinal nerve roots during surgery.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
ELEC2100
In Commercial Distribution
- 00810135960540 ()
- General internal orthopaedic fixation system implantation kit
Syringe Rack: MEDIUM, Holds 40 1cc-20cc Volume Syringes
Medco Manufacturing LLC
SR20-M-40
In Commercial Distribution
- 00810130453795 ()
- Test tube rack
Syringe Rack: MEDIUM, Holds 40 1cc-20cc Volume Syringes
Medco Manufacturing LLC
SR10-M-40
In Commercial Distribution
- 00810130453603 ()
- Test tube rack
Polypropylene Syringe Rack: Holds 40 10cc-20cc Volume Syringes
Medco Manufacturing LLC
SR20
In Commercial Distribution
- 00810130453436 ()
- Test tube rack