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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 Wiltrom Spinal Fixation System is comprised of screws, rods, cross-link connector and associated surgical instruments that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. The Wiltrom Spinal Fixation System is designed to be used to stabilize the vertebrae through a posterior approach. The Wiltrom spinal implants are made of Ti-6Al-4V ELI material which complies with ISO 5832-3 and ASTM F136. Wiltrom Spinal Fixation System is provided nonsterile, and the implants are for single use only.
WILTROM CO., LTD.
43587560 Polyaxial Reduction Pedicle Screw, Cannulated ø=7.5 L=60
In Commercial Distribution

  • 04719875729867 ()


  • Spinal bone screw, non-bioabsorbable
The Wiltrom Spinal Fixation System is comprised of screws, rods, cross-link connector and associated surgical instruments that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. The Wiltrom Spinal Fixation System is designed to be used to stabilize the vertebrae through a posterior approach. The Wiltrom spinal implants are made of Ti-6Al-4V ELI material which complies with ISO 5832-3 and ASTM F136. Wiltrom Spinal Fixation System is provided nonsterile, and the implants are for single use only.
WILTROM CO., LTD.
43587555 Polyaxial Reduction Pedicle Screw, Cannulated ø=7.5 L=55
In Commercial Distribution

  • 04719875729850 ()


  • Spinal bone screw, non-bioabsorbable
The Wiltrom Spinal Fixation System is comprised of screws, rods, cross-link connector and associated surgical instruments that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. The Wiltrom Spinal Fixation System is designed to be used to stabilize the vertebrae through a posterior approach. The Wiltrom spinal implants are made of Ti-6Al-4V ELI material which complies with ISO 5832-3 and ASTM F136. Wiltrom Spinal Fixation System is provided nonsterile, and the implants are for single use only.
WILTROM CO., LTD.
43587550 Polyaxial Reduction Pedicle Screw, Cannulated ø=7.5 L=50
In Commercial Distribution

  • 04719875729843 ()


  • Spinal bone screw, non-bioabsorbable
Wiltrom Orthopedic Surgical Instruments are manual instruments designed to be used in orthopedic procedures to assist implantation of Wiltrom implants. The Wiltrom Orthopedic Surgical Instruments are provided non-sterile and must be sterilized prior to use.
WILTROM CO., LTD.
70091 Pin M1.4*L500mm
In Commercial Distribution

  • 04719875729782 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
Wiltrom Orthopedic Surgical Instruments are manual instruments designed to be used in orthopedic procedures to assist implantation of Wiltrom implants. The Wiltrom Orthopedic Surgical Instruments are provided non-sterile and must be sterilized prior to use.
WILTROM CO., LTD.
75048 Pin M1.2*L171mm
In Commercial Distribution

  • 04719875729775 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
Wiltrom Orthopedic Surgical Instruments are manual instruments designed to be used in orthopedic procedures to assist implantation of Wiltrom implants. The Wiltrom Orthopedic Surgical Instruments are provided non-sterile and must be sterilized prior to use.
WILTROM CO., LTD.
75047 Pin M1.2*L167mm
In Commercial Distribution

  • 04719875729768 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
Wiltrom Orthopedic Surgical Instruments are manual instruments designed to be used in orthopedic procedures to assist implantation of Wiltrom implants. The Wiltrom Orthopedic Surgical Instruments are provided non-sterile and must be sterilized prior to use.
WILTROM CO., LTD.
75046 Pin M1.2*L121mm
In Commercial Distribution

  • 04719875729751 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
Wiltrom Orthopedic Surgical Instruments are manual instruments designed to be used in orthopedic procedures to assist implantation of Wiltrom implants. The Wiltrom Orthopedic Surgical Instruments are provided non-sterile and must be sterilized prior to use.
WILTROM CO., LTD.
75045 Pin M1.2*L117mm
In Commercial Distribution

  • 04719875729744 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
Bicera® Resorbable Bone Substitute is a bioceramic medical device that its composition of crystalline phase contains 60% hydroxyapatite (HAP) and 40% beta-tricalcium (ß-TCP). Bicera® Resorbable Bone Substitute is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Bicera® Resorbable Bone Substitute is indicated for use in the treatment of surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. Bicera® Resorbable Bone Substitute is intended to be packed into bony voids or gaps of the skeletal system (i.e., extremities, posterolateral spine and pelvis) as a bone void filler. This product provides a bone void filler that resorbs and is replaced by bone during the healing process.
WILTROM CO., LTD.
BC-G29(2.0-3.0mm,30c.c.)
In Commercial Distribution

  • 04719875722318 ()


  • Synthetic bone graft
Bicera® Resorbable Bone Substitute is a bioceramic medical device that its composition of crystalline phase contains 60% hydroxyapatite (HAP) and 40% beta-tricalcium (ß-TCP). Bicera® Resorbable Bone Substitute is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Bicera® Resorbable Bone Substitute is indicated for use in the treatment of surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. Bicera® Resorbable Bone Substitute is intended to be packed into bony voids or gaps of the skeletal system (i.e., extremities, posterolateral spine and pelvis) as a bone void filler. This product provides a bone void filler that resorbs and is replaced by bone during the healing process.
WILTROM CO., LTD.
BC-G28(2.0-3.0mm,20c.c.)
In Commercial Distribution

  • 04719875722301 ()


  • Synthetic bone graft
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