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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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No Description
Biomet Orthopedics, LLC
1707-20
In Commercial Distribution

  • 00887868004834 ()

  • 7MM X 20CM
170720

  • Humerus nail, non-sterile
No Description
Biomet Orthopedics, LLC
1707-18
In Commercial Distribution

  • 00887868004827 ()

  • 7MM X 18CM
170718

  • Humerus nail, non-sterile
Convenience kit containing Zinc PVA, Formalin and C&S Vials.
MEDICAL CHEMICAL CORPORATION
891-03
In Commercial Distribution

  • M445891030 ()
  • M445891031 ()
891-03

  • Fixative, metallic
  • 10% Neutral buffered formalin IVD
  • Carey-Blair transport medium IVD
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
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
M
Not in Commercial Distribution

  • 17350086550617 ()
  • 07350086550610 ()


  • 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
S
Not in Commercial Distribution

  • 17350086550600 ()
  • 07350086550603 ()


  • 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

  • 17350086550679 ()
  • 07350086550672 ()


  • 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

  • 17350086550662 ()
  • 07350086550665 ()


  • Custom-made orthopaedic surgical guide, sterile
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