NEXT ORTHOSURGICAL, INC. 9119-10-21-50-8 InterFuse L

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 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)

The TECOtherm Wrabbit is designed as disposable device to help prevent postnatal heat and water loss in premature and newborn infants.

Powder-free textured;The packages of proposed device including middle box package and outer carton package.Middle box package quantity: 100PCSOuter carton package quantity: 1000PCS

RITA Habib 4X Bipolar Resection Device, 10cm

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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 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 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 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)

The TECOtherm Wrabbit is designed as disposable device to help prevent postnatal heat and water loss in premature and newborn infants.

Powder-free textured;The packages of proposed device including middle box package and outer carton package.Middle box package quantity: 100PCSOuter carton package quantity: 1000PCS