Address:Rapsgatan 23A,Uppsala,SE
Device Description : OSSDSIGN Cranial PSI (Patient Specific Implant) is a device that replaces native OSSDSIGN Cranial PSI (Patient Specific Implant) is a device that replaces native bone in the cranial skeleton. Each Cranial PSI is a patient-specific device specifically created for a patient’s unique anatomical requirements. Cranial PSI consists of a rigid titanium mesh that is largely covered by biocompatible ceramic tiles. The ceramic tiles are in a mosaic pattern that provides space between tiles to allow free circulation of fluids (510(k) no. K161090)
Device Class :
Duns Number: 350354370
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : OSSDSIGN Cranial PSI (Patient Specific Implant) is a device that replaces native OSSDSIGN Cranial PSI (Patient Specific Implant) is a device that replaces native bone in the cranial skeleton. Each Cranial PSI is a patient-specific device specifically created for a patient’s unique anatomical requirements. Cranial PSI consists of a rigid titanium mesh that is largely covered by biocompatible ceramic tiles. The ceramic tiles are in a mosaic pattern that provides space between tiles to allow free circulation of fluids (510(k) no. K161090)
Device Class :
Duns Number: 350354370
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : OSSDSIGN Cranial PSI (Patient Specific Implant) is a device that replaces native OSSDSIGN Cranial PSI (Patient Specific Implant) is a device that replaces native bone in the cranial skeleton. Each Cranial PSI is a patient-specific device specifically created for a patient’s unique anatomical requirements. Cranial PSI consists of a rigid titanium mesh that is largely covered by biocompatible ceramic tiles. The ceramic tiles are in a mosaic pattern that provides space between tiles to allow free circulation of fluids (510(k) no. K161090)
Device Class :
Duns Number: 350354370
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : OSSDSIGN Cranial PSI (Patient Specific Implant) is a device that replaces native OSSDSIGN Cranial PSI (Patient Specific Implant) is a device that replaces native bone in the cranial skeleton. Each Cranial PSI is a patient-specific device specifically created for a patient’s unique anatomical requirements. Cranial PSI consists of a rigid titanium mesh that is largely covered by biocompatible ceramic tiles. The ceramic tiles are in a mosaic pattern that provides space between tiles to allow free circulation of fluids (510(k) no. K161090)
Device Class : 2
Duns Number: 350354370
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : OSSDSIGN Cranioplug is an osteoconductive calcium phosphate ceramic plug reinfor OSSDSIGN Cranioplug is an osteoconductive calcium phosphate ceramic plug reinforced with a titanium mesh plate which together provide the mechanicalperformance, safety and efficacy properties. The fully cured calcium phosphate ceramic fills the void in the burr hole. The osteoconductive ceramic component of Cranioplug resorbs and is replaced with bone during the healing process. Cranioplug is sized to match standard 11mm and 14mm burr hole perforators. (510(k) no. K181539)
Device Class :
Duns Number: 350354370
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : OSSDSIGN Cranioplug is an osteoconductive calcium phosphate ceramic plug reinfor OSSDSIGN Cranioplug is an osteoconductive calcium phosphate ceramic plug reinforced with a titanium mesh plate which together provide the mechanicalperformance, safety and efficacy properties. The fully cured calcium phosphate ceramic fills the void in the burr hole. The osteoconductive ceramic component of Cranioplug resorbs and is replaced with bone during the healing process. Cranioplug is sized to match standard 11mm and 14mm burr hole perforators. (510(k) no. K181539)
Device Class :
Duns Number: 350354370
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : OSSDSIGN Cranioplug is an osteoconductive calcium phosphate ceramic plug reinfor OSSDSIGN Cranioplug is an osteoconductive calcium phosphate ceramic plug reinforced with a titanium mesh plate which together provide the mechanical performance, safety and efficacy properties. The fully cured calcium phosphate ceramic fills the void in the burr hole. The osteoconductive ceramic component of Cranioplug resorbs and is replaced with bone during the healing process. Cranioplug is sized to match standard 11mm and 14mm burr hole perforators. (510(k) no. K181539)
Device Class :
Duns Number: 350354370
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : OSSDSIGN Cranioplug is an osteoconductive calcium phosphate ceramic plug reinfor OSSDSIGN Cranioplug is an osteoconductive calcium phosphate ceramic plug reinforced with a titanium mesh plate which together provide the mechanical performance, safety and efficacy properties. The fully cured calcium phosphate ceramic fills the void in the burr hole. The osteoconductive ceramic component of Cranioplug resorbs and is replaced with bone during the healing process. Cranioplug is sized to match standard 11mm and 14mm burr hole perforators. (510(k) no. K181539)
Device Class :
Duns Number: 350354370
Premarket Exempt : Yes
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