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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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Vertex - 00810005663915

Vertex Reusable Tray Base. The Vertex Nitinol Staple System consists of a series of nickel titanium alloy staple implants and the instruments necessary for the treatment of pathologies of the foot and ankle. The Vertex bone staples are made from superelastic nitinol that does not require cold storage or heating.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
STK-1000C-001
In Commercial Distribution

  • 00810005663915 ()


  • Surgical instrument/implant rack

Boundary - 00810005663908

Lumbar Buttress Plate INSERT 1 Lid. The Boundary Anterior Lumbar Buttress Plate is intended to stabilize the allograft or autograft at one level (L1-S1) as an aid to spinal fusion and to provide temporary stabilization and augment development of a solid spinal fusion. It may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials. This device is not intended for load bearing applications.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
BUT-1000C-104
In Commercial Distribution

  • 00810005663908 ()


  • Surgical instrument/implant rack

Boundary - 00810005663892

Lumbar Buttress Plate INSERT 1. The Boundary Anterior Lumbar Buttress Plate is intended to stabilize the allograft or autograft at one level (L1-S1) as an aid to spinal fusion and to provide temporary stabilization and augment development of a solid spinal fusion. It may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials. This device is not intended for load bearing applications.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
BUT-1000C-103
In Commercial Distribution

  • 00810005663892 ()


  • Surgical instrument/implant rack

Boundary - 00810005663885

Lumbar Buttress Plate Case Lid. The Boundary Anterior Lumbar Buttress Plate is intended to stabilize the allograft or autograft at one level (L1-S1) as an aid to spinal fusion and to provide temporary stabilization and augment development of a solid spinal fusion. It may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials. This device is not intended for load bearing applications.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
BUT-1000C-102
In Commercial Distribution

  • 00810005663885 ()


  • Surgical instrument/implant rack

Boundary - 00810005663878

Lumbar Buttress Plate Case Base. The Boundary Anterior Lumbar Buttress Plate is intended to stabilize the allograft or autograft at one level (L1-S1) as an aid to spinal fusion and to provide temporary stabilization and augment development of a solid spinal fusion. It may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials. This device is not intended for load bearing applications.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
BUT-1000C-101
In Commercial Distribution

  • 00810005663878 ()


  • Surgical instrument/implant rack

Healix - 00810005662826

4.0 Instrument Caddy. The HEALIX Compression Screw (HCS) System is indicated for Bone Fractures, Osteotomies, Arthrodesis, Osteochondritis, and Tendon Reattachment. It is intended for, but not limited to, Hand Surgery, Orthopedic Surgery, and Podiatric Surgery but is not intended for attachment or fixation to the posterior elements (pedicles) of the spine.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
CS-1200C-115
In Commercial Distribution

  • 00810005662826 ()


  • Surgical instrument/implant rack

Healix - 00810005662819

CS-40 Caddy Base. The HEALIX Compression Screw (HCS) System is indicated for Bone Fractures, Osteotomies, Arthrodesis, Osteochondritis, and Tendon Reattachment. It is intended for, but not limited to, Hand Surgery, Orthopedic Surgery, and Podiatric Surgery but is not intended for attachment or fixation to the posterior elements (pedicles) of the spine.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
CS-1200C-113
In Commercial Distribution

  • 00810005662819 ()


  • Surgical instrument/implant rack

Healix - 00810005662802

3.5 Instrument Caddy. The HEALIX Compression Screw (HCS) System is indicated for Bone Fractures, Osteotomies, Arthrodesis, Osteochondritis, and Tendon Reattachment. It is intended for, but not limited to, Hand Surgery, Orthopedic Surgery, and Podiatric Surgery but is not intended for attachment or fixation to the posterior elements (pedicles) of the spine.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
CS-1200C-111
In Commercial Distribution

  • 00810005662802 ()


  • Surgical instrument/implant rack

Healix - 00810005662796

CS-35 Caddy Base. The HEALIX Compression Screw (HCS) System is indicated for Bone Fractures, Osteotomies, Arthrodesis, Osteochondritis, and Tendon Reattachment. It is intended for, but not limited to, Hand Surgery, Orthopedic Surgery, and Podiatric Surgery but is not intended for attachment or fixation to the posterior elements (pedicles) of the spine.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
CS-1200C-109
In Commercial Distribution

  • 00810005662796 ()


  • Surgical instrument/implant rack

Healix - 00810005662789

CS-25 Caddy Base. The HEALIX Compression Screw (HCS) System is indicated for Bone Fractures, Osteotomies, Arthrodesis, Osteochondritis, and Tendon Reattachment. It is intended for, but not limited to, Hand Surgery, Orthopedic Surgery, and Podiatric Surgery but is not intended for attachment or fixation to the posterior elements (pedicles) of the spine.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
CS-1200C-103
In Commercial Distribution

  • 00810005662789 ()


  • Surgical instrument/implant rack
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