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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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Non-bioabsorbable orthopaedic bone pin intended to become part of an assembly of non-sterile devices designed to stabilize fractured bones to promote treatment and healing. It typically consists of an external plastic and/or metallic fixator (a framework) and other external and/or implantable components such as clamps, rods, rings, pins, bolts, and nuts, as well as some reusable instrumentation (e.g., wrenches, depth gauge, tensioner). It is used mainly to help the healing of long bones such as the femur, tibia and humerus, as well as fractures of the foot and ankle, joint fusions, and limb lengthening. This is a single-use device intended to be sterilized prior to use.
GEXFIX SA
2015-1020
In Commercial Distribution

  • 07640136270354 ()


  • Orthopaedic bone pin, non-bioabsorbable
Non-bioabsorbable orthopaedic bone pin intended to become part of an assembly of non-sterile devices designed to stabilize fractured bones to promote treatment and healing. It typically consists of an external plastic and/or metallic fixator (a framework) and other external and/or implantable components such as clamps, rods, rings, pins, bolts, and nuts, as well as some reusable instrumentation (e.g., wrenches, depth gauge, tensioner). It is used mainly to help the healing of long bones such as the femur, tibia and humerus, as well as fractures of the foot and ankle, joint fusions, and limb lengthening. This is a single-use device intended to be sterilized prior to use.
GEXFIX SA
2010-1020
In Commercial Distribution

  • 07640136270347 ()


  • Orthopaedic bone pin, non-bioabsorbable
Catheter Cable
BOSTON SCIENTIFIC CORPORATION
M004RARC040
In Commercial Distribution

  • 00191506020408 ()

  • Length: 200 Centimeter
M004RARC040

  • Electrical-only medical device connection cable, reusable
The Integra External Fixation System two-post bridge is manufactured from stainless steel. It is intended for the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of external fixation.
Ascension Orthopedics, Inc.
12225223
Not in Commercial Distribution

  • 10381780125679 ()

  • 1.116 in L x 1.107 in W
12225223

  • External orthopaedic fixation system, reusable
The Integra External Fixation System three-hole plate is manufactured from stainless steel. It is intended for the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of external fixation.
Ascension Orthopedics, Inc.
12224217
In Commercial Distribution

  • 10381780125327 ()

  • 2.72 in L
12224217

  • External orthopaedic fixation system, reusable
The Integra Silicone PIP is intended for replacement of the proximal interphalangeal (PIP) joint where disabled by rheumatoid, degenerative, or traumatic arthritis. This set includes silicone PIP trials to evaluate size and fit of the implants. Instruments are also included.
Ascension Orthopedics, Inc.
SILPIPINSTP
Not in Commercial Distribution

  • M268SILPIPINSTP1 ()
  • 10381780235125 ()

  • 21.9 in L x 10.2 in W x 3.0 in H


  • General external orthopaedic fixation system implantation kit, reusable
The Glenoid IRI Leg (25mm) is a component of the Glenoid Intelligent Reusable Instrument (IRI). The Glenoid IRI Leg (25mm) is indicated for use as part of the Arthrex Glenoid Intelligent Reusable Instrument System (IRIS) for Total Shoulder Arthroplasty (TSA).
CUSTOM ORTHOPAEDIC SOLUTIONS, INC.
L
Not in Commercial Distribution

  • 00811813020198 ()

  • Length: 25 Millimeter
0006-0005-25

  • Orthopaedic prosthesis implantation positioning instrument, reusable
  • Orthopaedic implant/instrument assembling device
The Glenoid IRI Leg (24mm) is a component of the Glenoid Intelligent Reusable Instrument (IRI). The Glenoid IRI Leg (24mm) is indicated for use as part of the Arthrex Glenoid Intelligent Reusable Instrument System (IRIS) for Total Shoulder Arthroplasty (TSA).
CUSTOM ORTHOPAEDIC SOLUTIONS, INC.
L
Not in Commercial Distribution

  • 00811813020181 ()

  • Length: 24 Millimeter
0006-0005-24

  • Orthopaedic implant/instrument assembling device
  • Orthopaedic prosthesis implantation positioning instrument, reusable
The Glenoid IRI Leg (23mm) is a component of the Glenoid Intelligent Reusable Instrument (IRI). The Glenoid IRI Leg (23mm) is indicated for use as part of the Arthrex Glenoid Intelligent Reusable Instrument System (IRIS) for Total Shoulder Arthroplasty (TSA).
CUSTOM ORTHOPAEDIC SOLUTIONS, INC.
L
Not in Commercial Distribution

  • 00811813020174 ()

  • Length: 23 Millimeter
0006-0005-23

  • Orthopaedic implant/instrument assembling device
  • Orthopaedic prosthesis implantation positioning instrument, reusable
The Glenoid IRI Leg (22mm) is a component of the Glenoid Intelligent Reusable Instrument (IRI). The Glenoid IRI Leg (22mm) is indicated for use as part of the Arthrex Glenoid Intelligent Reusable Instrument System (IRIS) for Total Shoulder Arthroplasty (TSA).
CUSTOM ORTHOPAEDIC SOLUTIONS, INC.
L
Not in Commercial Distribution

  • 00811813020167 ()
0006-0005-22

  • Orthopaedic prosthesis implantation positioning instrument, reusable
  • Orthopaedic implant/instrument assembling device
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