MEDLINE INDUSTRIES, INC. SPT-2728CS Medline Industries, Inc.

nitrile, blue, XL

nitrile, blue, XL

nitrile, blue, XL

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)

HYH,STERIL,SLV,-,-,100

GOWN,SURGICAL,AURORA,SLEEVE

PMMA Patient Specific Cranial Implant (Non-Sterile)

Grayscale/Color Desktop XL Format Film and Paper Diagnostic Imager

vinyl, clear, XL

vinyl, Blue, XL

nitrile, blue, XL

nitrile, blue, XL

nitrile, blue, XL

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)