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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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EARP INSTRUMENTS - 00810135960953

EARP, IMPLANT CADDIE 14X35. 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-IC_1435
In Commercial Distribution

  • 00810135960953 ()


  • Surgical instrument/implant rack

EARP INSTRUMENTS - 00810135960946

EARP, IMPLANT CADDIE 14X30. 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-IC_1430
In Commercial Distribution

  • 00810135960946 ()


  • Surgical instrument/implant rack

EARP INSTRUMENTS - 00810135960939

EARP, IMPLANT CADDIE 14X25. 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-IC_1425
In Commercial Distribution

  • 00810135960939 ()


  • Surgical instrument/implant rack

EARP INSTRUMENTS - 00810135960922

EARP, DISC SPACER CADDIE. 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-DC
In Commercial Distribution

  • 00810135960922 ()


  • Surgical instrument/implant rack

EARP INSTRUMENTS - 00810135960915

EARP, TRIAL CADDIE 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-TC
In Commercial Distribution

  • 00810135960915 ()


  • Surgical instrument/implant rack

NA - 20887587059270

NANO INSERT TRAY DIVIDER SINGLE WIDE/2 HIGH
Synthes GmbH
68.590.032.05
In Commercial Distribution

  • 07611819663947 ()
  • H98068590032050 ()
  • 20887587059270 ()
  • 80887587059272 ()
6859003205

  • Surgical instrument/implant rack

NA - 20887587059256

NANO INSERT TRAY DIVIDER SINGLE WIDE/1 HIGH
Synthes GmbH
68.590.031.05
In Commercial Distribution

  • 07611819663923 ()
  • H98068590031050 ()
  • 20887587059256 ()
  • 80887587059258 ()
6859003105

  • Surgical instrument/implant rack

NA - 20887587032471

CORNER POSTS FOR MMFS UPGRADE
Synthes GmbH
304.738
In Commercial Distribution

  • H9803047380 ()
  • 20887587032471 ()
  • 80887587032473 ()
304738

  • Surgical instrument/implant rack

NA - 20887587030583

SCREW LENGTH MARKER 40MM
Synthes GmbH
304.140
In Commercial Distribution

  • H9803041400 ()
  • 20887587030583 ()
  • 80887587030585 ()
304140

  • Surgical instrument/implant rack

NA - 20887587030576

SCREW LENGTH MARKER 38MM
Synthes GmbH
304.138
In Commercial Distribution

  • H9803041380 ()
  • 20887587030576 ()
  • 80887587030578 ()
304138

  • Surgical instrument/implant rack
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