Address:Rapsgatan 23A,Uppsala,SE
Device Description : OSSDSIGN Cranial PSI Accessories are optional devices that support physician use 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)
Device Class : 2
Duns Number: 350354370
Premarket Exempt : No
Prescription Use : Yes
Device Description : OSSDSIGN Cranial PSI Accessories are optional devices that support physician use 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)
Device Class : 2
Duns Number: 350354370
Premarket Exempt : No
Prescription Use : Yes
Device Description : OSSDSIGN Cranial PSI Accessories are optional devices that support physician use 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)
Device Class : 2
Duns Number: 350354370
Premarket Exempt : No
Prescription Use : Yes
Device Description : OSSDSIGN Cranial PSI Accessories are optional devices that support physician use 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)
Device Class : 2
Duns Number: 350354370
Premarket Exempt : No
Prescription Use : Yes
Device Description : OSSDSIGN Cranial PSI Accessories are optional devices that support physician use 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)
Device Class : 2
Duns Number: 350354370
Premarket Exempt : No
Prescription Use : Yes
Device Description : OSSDSIGN Cranial PSI Accessories are optional devices that support physician use 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)
Device Class : 2
Duns Number: 350354370
Premarket Exempt : No
Prescription Use : Yes
Device Description : OSSDSIGN Cranial PSI Accessories are optional devices that support physician use 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)
Device Class : 2
Duns Number: 350354370
Premarket Exempt : No
Prescription Use : Yes
Device Description : OSSDSIGN Cranial PSI Accessories are optional devices that support physician use 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)
Device Class : 2
Duns Number: 350354370
Premarket Exempt : No
Prescription Use : Yes
Device Description : OssDsign Catalyst is an osteoconductive, resorbable, porous, 100% nanosynthetic OssDsign Catalyst is an osteoconductive, resorbable, porous, 100% nanosynthetic calcium phosphate bone void filler. OssDsign Catalyst contains 5.8 wt% silicon-substituted calcium phosphate granules suspended in a resorbable polymer gel. The final, finished OssDsign Catalyst is 30 wt% granules and 70 wt% polymer gel. The high surface area porous granules have been designed to deliver consistent and rapid bone ingrowth, remodeling and cell-mediated resorption during the bone healing process. The aqueous polymer gel phase binds the highly porous granules into a moldable, pliable formulation which enables OssDsign Catalyst to be implanted directly from the packaging without any further gelation, mixing or graft setting time. OssDsign Catalyst is provided sterile to the end user in 2.5 cc, 5 cc and 10 cc sizes. (510(k) no. K193075)
Device Class : 2
Duns Number: 350354370
Premarket Exempt : No
Prescription Use : Yes
Device Description : OssDsign Catalyst is an osteoconductive, resorbable, porous, 100% nanosynthetic OssDsign Catalyst is an osteoconductive, resorbable, porous, 100% nanosynthetic calcium phosphate bone void filler. OssDsign Catalyst contains 5.8 wt% silicon-substituted calcium phosphate granules suspended in a resorbable polymer gel. The final, finished OssDsign Catalyst is 30 wt% granules and 70 wt% polymer gel. The high surface area porous granules have been designed to deliver consistent and rapid bone ingrowth, remodeling and cell-mediated resorption during the bone healing process. The aqueous polymer gel phase binds the highly porous granules into a moldable, pliable formulation which enables OssDsign Catalyst to be implanted directly from the packaging without any further gelation, mixing or graft setting time. OssDsign Catalyst is provided sterile to the end user in 2.5 cc, 5 cc and 10 cc sizes. (510(k) no. K193075)
Device Class : 2
Duns Number: 350354370
Premarket Exempt : No
Prescription Use : Yes