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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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Infinion CX, 70cm 16 Contact Lead Kit
BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
SC-2317-70
In Commercial Distribution

  • M365SC2317700 ()

  • 70 cm Length
SC-2317-70

  • Analgesic spinal cord electrical stimulation system
Infinion CX, 50cm 16 Contact Trial Lead Kit
BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
SC-2317-50E
In Commercial Distribution

  • M365SC231750E0 ()

  • 50 cm Length
SC-2317-50E

  • Analgesic spinal cord electrical stimulation system
Infinion CX, 50cm 16 Contact Lead Kit
BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
SC-2317-50
In Commercial Distribution

  • M365SC2317500 ()

  • 50 cm Length
SC-2317-50

  • Analgesic spinal cord electrical stimulation system
Infinion 16, 70cm 16 Contact Trial Lead Kit
BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
SC-2316-70E
In Commercial Distribution

  • M365SC231670E0 ()

  • 70 cm Length
SC-2316-70E

  • Analgesic spinal cord electrical stimulation system
Infinion 16, 70cm 16 Contact Lead Kit
BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
SC-2316-70
In Commercial Distribution

  • M365SC2316700 ()

  • 70 cm Length
SC-2316-70

  • Analgesic spinal cord electrical stimulation system
Infinion 16, 50cm 16 Contact Trial Lead Kit
BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
SC- 2316-50E
In Commercial Distribution

  • M365SC231650E0 ()

  • 50 cm Length
SC- 2316-50E

  • Analgesic spinal cord electrical stimulation system
Infinion 16, 50cm 16 Contact Lead Kit
BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
SC-2316-50
In Commercial Distribution

  • M365SC2316500 ()

  • 50 cm Length
SC-2316-50

  • Analgesic spinal cord electrical stimulation system
OSSDSIGN Cranial PSI Accessories are optional devices that support physician use of the OSSDSIGN Cranial PSI (K161090) parent device. They are additively manufactured from PA2200 polyamide material. Each Cranial PSI Accessory is patient-specific and corresponds to a patient’s unique anatomical requirements. Cranial PSI Accessories are intended to support implantation of the corresponding Cranial PSI parent device; both devices are designed from the same patient-specific computed tomography image data set. (510(k) no. K190523)
Ossdsign AB
S
Not in Commercial Distribution

  • 17350086550648 ()
  • 07350086550641 ()


  • Custom-made orthopaedic surgical guide, sterile
OSSDSIGN Cranial PSI Accessories are optional devices that support physician use of the OSSDSIGN Cranial PSI (K161090) parent device. They are additively manufactured from PA2200 polyamide material. Each Cranial PSI Accessory is patient-specific and corresponds to a patient’s unique anatomical requirements. Cranial PSI Accessories are intended to support implantation of the corresponding Cranial PSI parent device; both devices are designed from the same patient-specific computed tomography image data set. (510(k) no. K190523)
Ossdsign AB
XL
Not in Commercial Distribution

  • 17350086550631 ()
  • 07350086550634 ()


  • Custom-made orthopaedic surgical guide, sterile
OSSDSIGN Cranial PSI Accessories are optional devices that support physician use of the OSSDSIGN Cranial PSI (K161090) parent device. They are additively manufactured from PA2200 polyamide material. Each Cranial PSI Accessory is patient-specific and corresponds to a patient’s unique anatomical requirements. Cranial PSI Accessories are intended to support implantation of the corresponding Cranial PSI parent device; both devices are designed from the same patient-specific computed tomography image data set. (510(k) no. K190523)
Ossdsign AB
L
Not in Commercial Distribution

  • 17350086550624 ()
  • 07350086550627 ()


  • Custom-made orthopaedic surgical guide, sterile
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