ORTHOPEDIATRICS CORP. 01-1500-0406 PediNail

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)

Product : NPFSize : XL

vinyl, clear, XL

vinyl, Blue, XL

Ndlctr: Foam/Mag 10Ct 96/Cs

CIRCULAR MECH XL SEAL 25MM

CIRCULAR MECH XL SEAL 29MM

Surgical Tray (no instruments)

Simplify® Tray 3 Level

Grayscale/Color Desktop XL Format Film and Paper Diagnostic Imager

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)

Product : NPFSize : XL

vinyl, clear, XL

vinyl, Blue, XL