WILTROM CO., LTD.

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Device Description : The Wiltrom Spinal Fixation System is comprised of screws, rods, cross-link conn The Wiltrom Spinal Fixation System is comprised of screws, rods, cross-link connector and associated surgical instruments thatallow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. The Wiltrom SpinalFixation System is designed to be used to stabilize the vertebrae through a posterior approach. The Wiltrom spinal implants aremade 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.

Device Class : 2

Duns Number: 656680902

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Device Description : The Wiltrom Spinal Fixation System is comprised of screws, rods, cross-link conn The Wiltrom Spinal Fixation System is comprised of screws, rods, cross-link connector and associated surgical instruments thatallow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. The Wiltrom SpinalFixation System is designed to be used to stabilize the vertebrae through a posterior approach. The Wiltrom spinal implants aremade 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.

Device Class : 2

Duns Number: 656680902

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Device Description : The Wiltrom Spinal Fixation System is comprised of screws, rods, cross-link conn The Wiltrom Spinal Fixation System is comprised of screws, rods, cross-link connector and associated surgical instruments thatallow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. The Wiltrom SpinalFixation System is designed to be used to stabilize the vertebrae through a posterior approach. The Wiltrom spinal implants aremade 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.

Device Class : 2

Duns Number: 656680902

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Device Description : The Wiltrom Spinal Fixation System is comprised of screws, rods, cross-link conn The Wiltrom Spinal Fixation System is comprised of screws, rods, cross-link connector and associated surgical instruments thatallow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. The Wiltrom SpinalFixation System is designed to be used to stabilize the vertebrae through a posterior approach. The Wiltrom spinal implants aremade 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.

Device Class : 2

Duns Number: 656680902

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Device Description : The Wiltrom Spinal Fixation System is comprised of screws, rods, cross-link conn The Wiltrom Spinal Fixation System is comprised of screws, rods, cross-link connector and associated surgical instruments thatallow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. The Wiltrom SpinalFixation System is designed to be used to stabilize the vertebrae through a posterior approach. The Wiltrom spinal implants aremade 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.

Device Class : 2

Duns Number: 656680902

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Device Description : The Wiltrom Spinal Fixation System is comprised of screws, rods, cross-link conn The Wiltrom Spinal Fixation System is comprised of screws, rods, cross-link connector and associated surgical instruments thatallow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. The Wiltrom SpinalFixation System is designed to be used to stabilize the vertebrae through a posterior approach. The Wiltrom spinal implants aremade 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.

Device Class : 2

Duns Number: 656680902

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Device Description : Bicera® Resorbable Bone Substitute is a bioceramic medical device that its compo 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.

Device Class : 2

Duns Number: 656680902

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

Device Description : Bicera® Resorbable Bone Substitute is a bioceramic medical device that its compo 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.

Device Class : 2

Duns Number: 656680902

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

Device Description : Bicera® Resorbable Bone Substitute is a bioceramic medical device that its compo 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.

Device Class : 2

Duns Number: 656680902

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

Device Description : Bicera® Resorbable Bone Substitute is a bioceramic medical device that its compo 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.

Device Class : 2

Duns Number: 656680902

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1