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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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The Ascension® NuGrip® is an uncemented, one-component prosthesis for the basal thumb joint. It has a proximal head that articulates against the trapezium, a planar collar that provides for a simple planar bone resection, and an anatomic shaped stem that is press fit into the canal of the first metacarpal following resection of the base. It is fabricated from a thick pyrocarbon layer encasing a graphite core that is impregnated with one-atomic percent tungsten so it is radiopaque. The Ascension® NuGrip® is intended to replace the proximal end of the first metacarpal in cases of rheumatoid arthritis, traumatic arthritis, osteoarthritis or post fracture deformation or bone loss which present as either a painful, unstable thumb, or a thumb with limited range of motion.
Ascension Orthopedics, Inc.
NUG44330L
In Commercial Distribution

  • 10381780120094 ()
  • M268NUG44330L1 ()

  • 1.313 in L; Size 30 L
NUG-443-30L

  • Metacarpal prosthesis
The Ascension® NuGrip® is an uncemented, one-component prosthesis for the basal thumb joint. It has a proximal head that articulates against the trapezium, a planar collar that provides for a simple planar bone resection, and an anatomic shaped stem that is press fit into the canal of the first metacarpal following resection of the base. It is fabricated from a thick pyrocarbon layer encasing a graphite core that is impregnated with one-atomic percent tungsten so it is radiopaque. The Ascension® NuGrip® is intended to replace the proximal end of the first metacarpal in cases of rheumatoid arthritis, traumatic arthritis, osteoarthritis or post fracture deformation or bone loss which present as either a painful, unstable thumb, or a thumb with limited range of motion.
Ascension Orthopedics, Inc.
NUG44320S
In Commercial Distribution

  • 10381780120087 ()
  • M268NUG44320S1 ()

  • 1.081 in L; Size 20 S
NUG-443-20S

  • Metacarpal prosthesis
The Ascension® NuGrip® is an uncemented, one-component prosthesis for the basal thumb joint. It has a proximal head that articulates against the trapezium, a planar collar that provides for a simple planar bone resection, and an anatomic shaped stem that is press fit into the canal of the first metacarpal following resection of the base. It is fabricated from a thick pyrocarbon layer encasing a graphite core that is impregnated with one-atomic percent tungsten so it is radiopaque. The Ascension® NuGrip® is intended to replace the proximal end of the first metacarpal in cases of rheumatoid arthritis, traumatic arthritis, osteoarthritis or post fracture deformation or bone loss which present as either a painful, unstable thumb, or a thumb with limited range of motion.
Ascension Orthopedics, Inc.
NUG44320M
In Commercial Distribution

  • 10381780120070 ()
  • M268NUG44320M1 ()

  • 1.147 in L; Size 20 M
NUG-443-20M

  • Metacarpal prosthesis
The Ascension® NuGrip® is an uncemented, one-component prosthesis for the basal thumb joint. It has a proximal head that articulates against the trapezium, a planar collar that provides for a simple planar bone resection, and an anatomic shaped stem that is press fit into the canal of the first metacarpal following resection of the base. It is fabricated from a thick pyrocarbon layer encasing a graphite core that is impregnated with one-atomic percent tungsten so it is radiopaque. The Ascension® NuGrip® is intended to replace the proximal end of the first metacarpal in cases of rheumatoid arthritis, traumatic arthritis, osteoarthritis or post fracture deformation or bone loss which present as either a painful, unstable thumb, or a thumb with limited range of motion.
Ascension Orthopedics, Inc.
NUG44310S
In Commercial Distribution

  • 10381780120063 ()
  • M268NUG44310S1 ()

  • 1.019 in L; Size 10 S
NUG-443-10S

  • Metacarpal prosthesis
The Ascension® NuGrip® is an uncemented, one-component prosthesis for the basal thumb joint. It has a proximal head that articulates against the trapezium, a planar collar that provides for a simple planar bone resection, and an anatomic shaped stem that is press fit into the canal of the first metacarpal following resection of the base. It is fabricated from a thick pyrocarbon layer encasing a graphite core that is impregnated with one-atomic percent tungsten so it is radiopaque. The Ascension® NuGrip® is intended to replace the proximal end of the first metacarpal in cases of rheumatoid arthritis, traumatic arthritis, osteoarthritis or post fracture deformation or bone loss which present as either a painful, unstable thumb, or a thumb with limited range of motion.
Ascension Orthopedics, Inc.
NUG44310M
In Commercial Distribution

  • 10381780120056 ()
  • M268NUG44310M1 ()

  • 1.085 in L; Size 10 M
NUG-443-10M

  • Metacarpal prosthesis
The KALIX II Flat Foot implant is a combination of three sterile components. Two of them are made from Titanium alloy, and the outer sleeve is made from Ultra High Molecular Weight Polyethylene. The implant is indicated for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block forward, downward and medial displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela. Available in different sizes.
NEWDEAL
141017ND
Not in Commercial Distribution

  • M248141017ND1 ()
  • 10381780048220 ()

  • 17mm diameter
141017ND

  • Subtalar implant, non-bioabsorbable
The KALIX II Flat Foot implant is a combination of three sterile components. Two of them are made from Titanium alloy, and the outer sleeve is made from Ultra High Molecular Weight Polyethylene. The implant is indicated for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block forward, downward and medial displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela. Available in different sizes.
NEWDEAL
141015ND
Not in Commercial Distribution

  • M248141015ND1 ()
  • 10381780048213 ()

  • 15mm diameter
141015ND

  • Subtalar implant, non-bioabsorbable
The KALIX II Flat Foot implant is a combination of three sterile components. Two of them are made from Titanium alloy, and the outer sleeve is made from Ultra High Molecular Weight Polyethylene. The implant is indicated for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block forward, downward and medial displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela. Available in different sizes.
NEWDEAL
141014ND
Not in Commercial Distribution

  • M248141014ND1 ()
  • 10381780048206 ()

  • 14mm diameter
141014ND

  • Subtalar implant, non-bioabsorbable
The KALIX II Flat Foot implant is a combination of three sterile components. Two of them are made from Titanium alloy, and the outer sleeve is made from Ultra High Molecular Weight Polyethylene. The implant is indicated for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block forward, downward and medial displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela. Available in different sizes.
NEWDEAL
141013ND
Not in Commercial Distribution

  • M248141013ND1 ()
  • 10381780048190 ()

  • 13mm diameter
141013ND

  • Subtalar implant, non-bioabsorbable
The KALIX II Flat Foot implant is a combination of three sterile components. Two of them are made from Titanium alloy, and the outer sleeve is made from Ultra High Molecular Weight Polyethylene. The implant is indicated for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block forward, downward and medial displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela. Available in different sizes.
NEWDEAL
141012ND
Not in Commercial Distribution

  • M248141012ND1 ()
  • 10381780048183 ()

  • 12mm diameter
141012ND

  • Subtalar implant, non-bioabsorbable
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