Other products from "OSSDSIGN AB"
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 07350086550719 5cc 104050 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) MQV Filler, Bone Void, Calcium Compound 2 OssDsign Catalyst
2 07350086550702 10cc 104100 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) MQV Filler, Bone Void, Calcium Compound 2 OssDsign Catalyst
3 07350086550252 11 mm, 6 fixation-points 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) GXR Cover, Burr Hole OSSDSIGN Cranioplug
4 07350086550245 11 mm, 2 fixation-points 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) GXR Cover, Burr Hole OSSDSIGN Cranioplug
5 07350086550238 14 mm, 6 fixation-points 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) GXR Cover, Burr Hole OSSDSIGN Cranioplug
6 07350086550221 14 mm, 2 fixation-points n/a 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) GXR Cover, Burr Hole OSSDSIGN Cranioplug
7 07350086550115 XL 101011 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) GXN Plate, Cranioplasty, Preformed, Non-Alterable 2 OSSDSIGN Cranial PSI
8 07350086550108 L 101010 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) GXN Plate, Cranioplasty, Preformed, Non-Alterable OSSDSIGN Cranial PSI
9 07350086550092 M 101009 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) GXN Plate, Cranioplasty, Preformed, Non-Alterable OSSDSIGN Cranial PSI
10 07350086550085 S 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) GXN Plate, Cranioplasty, Preformed, Non-Alterable OSSDSIGN Cranial PSI
11 07350086550627 L 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) PJN Filler, Bone Void, Non-Alterable Compound For Cranioplasty 2 Anatomical Model Original
12 07350086550634 XL 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) PJN Filler, Bone Void, Non-Alterable Compound For Cranioplasty 2 Anatomical Model Original
13 07350086550610 M 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) PJN Filler, Bone Void, Non-Alterable Compound For Cranioplasty 2 Anatomical Model Original
14 07350086550603 S 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) PJN Filler, Bone Void, Non-Alterable Compound For Cranioplasty 2 Anatomical Model Original
15 07350086550436 Whole skull 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) PJN Filler, Bone Void, Non-Alterable Compound For Cranioplasty 2 Anatomical Model Original
16 07350086550429 Half skull 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) PJN Filler, Bone Void, Non-Alterable Compound For Cranioplasty 2 Anatomical Model Original
17 07350086550597 XL 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) PJN Filler, Bone Void, Non-Alterable Compound For Cranioplasty 2 Cranial Implant Trial
18 07350086550580 L 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) PJN Filler, Bone Void, Non-Alterable Compound For Cranioplasty 2 Cranial Implant Trial
19 07350086550573 M 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) PJN Filler, Bone Void, Non-Alterable Compound For Cranioplasty 2 Cranial Implant Trial
20 07350086550566 S 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) PJN Filler, Bone Void, Non-Alterable Compound For Cranioplasty 2 Cranial Implant Trial
21 07350086550559 XL 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) PJN Filler, Bone Void, Non-Alterable Compound For Cranioplasty 2 Plastic Drawing Guide
22 07350086550542 L 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) PJN Filler, Bone Void, Non-Alterable Compound For Cranioplasty 2 Plastic Drawing Guide
23 07350086550535 M 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) PJN Filler, Bone Void, Non-Alterable Compound For Cranioplasty 2 Plastic Drawing Guide
24 07350086550528 S 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) PJN Filler, Bone Void, Non-Alterable Compound For Cranioplasty 2 Plastic Drawing Guide
25 07350086550672 XL 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) PJN Filler, Bone Void, Non-Alterable Compound For Cranioplasty 2 Anatomical Model Modified
26 07350086550665 L 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) PJN Filler, Bone Void, Non-Alterable Compound For Cranioplasty 2 Anatomical Model Modified
27 07350086550658 M 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) PJN Filler, Bone Void, Non-Alterable Compound For Cranioplasty 2 Anatomical Model Modified
28 07350086550641 S 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) PJN Filler, Bone Void, Non-Alterable Compound For Cranioplasty 2 Anatomical Model Modified
29 07350086550511 Whole skull 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) PJN Filler, Bone Void, Non-Alterable Compound For Cranioplasty 2 Anatomical Model Modified
30 07350086550504 Half skull 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) PJN Filler, Bone Void, Non-Alterable Compound For Cranioplasty 2 Anatomical Model Modified
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