3D SYSTEMS, INC.

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Device Description : A three dimensional physical model depicting allograft specific modified anatomy A three dimensional physical model depicting allograft specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants.

Device Class : 2

Duns Number: 085049749

Premarket Exempt : No

Product Code : PBF

Prescription Use : Yes

Device Count : 1

Device Description : A three dimensional physical model depicting patient specific modified anatomy. A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants.

Device Class : 2

Duns Number: 085049749

Premarket Exempt : No

Product Code : PBF

Prescription Use : Yes

Device Count : 1

Device Description : A three dimensional physical model depicting patient specific modified anatomy. A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants.

Device Class : 2

Duns Number: 085049749

Premarket Exempt : No

Product Code : PBF

Prescription Use : Yes

Device Count : 1

Device Description : A three dimensional physical model depicting patient specific modified anatomy. A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants.

Device Class : 2

Duns Number: 085049749

Premarket Exempt : No

Product Code : PBF

Prescription Use : Yes

Device Count : 1

Device Description : A three dimensional physical model depicting allograft specific modified anatomy A three dimensional physical model depicting allograft specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants.

Device Class : 2

Duns Number: 085049749

Premarket Exempt : No

Product Code : PBF

Prescription Use : Yes

Device Count : 1

Device Description : A three dimensional physical model depicting patient specific modified anatomy. A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants.

Device Class : 2

Duns Number: 085049749

Premarket Exempt : No

Product Code : PBF

Prescription Use : Yes

Device Count : 1

Device Description : A three dimensional physical model depicting patient specific modified anatomy. A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants.

Device Class : 2

Duns Number: 085049749

Premarket Exempt : No

Product Code : PBF

Prescription Use : Yes

Device Count : 1

Device Description : A three dimensional physical model depicting patient specific modified anatomy. A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants.

Device Class : 2

Duns Number: 085049749

Premarket Exempt : No

Product Code : PBF

Prescription Use : Yes

Device Count : 1

Device Description : A three dimensional physical model depicting patient specific modified anatomy. A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants.

Device Class : 2

Duns Number: 085049749

Premarket Exempt : No

Product Code : PBF

Prescription Use : Yes

Device Count : 1

Device Description : Reusable accessory drill guide

Device Class : 2

Duns Number: 085049749

Premarket Exempt : No

Product Code : PBF

Prescription Use : Yes

Device Count : 1