3D SYSTEMS, INC.

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

System, Image Processing, Radiological (LLZ) (5) Cranial Surgical Planning And Instrument Guides (PPT) (4) Driver, Wire, And Bone Drill, Manual (DZJ) (4) Orthopaedic Surgical Planning And Instrument Guides (PBF) (1)

Premarket Exempt

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VSP Orthopedics - 00816847022552 Catalog Number :

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.

Device Class : 2

Duns Number: 085049749

Premarket Exempt : No

Product Code : PBF

Prescription Use : Yes

Device Count : 1

D2P - 00816847022569 Catalog Number :

Device Description : The D2P software is a stand-alone modular software package that provides advance The D2P software is a stand-alone modular software package that provides advanced visualization of DICOM imaging data. This modular package includes, but is not limited to the following functions:- DICOM viewer and analysis- Automated segmentation- Editing and pre-printing- Seamless integration with 3D Systems printers- Seamless integration with 3D Systems software packages- Seamless integration with Virtual Reality visualization for non-diagnostic use

Device Class : 2

Duns Number: 085049749

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

Vantage PSI - 00816847022576 Catalog Number : 351-80-00

Device Description : A physical guide that is composed of patient's bony anatomy and allows for preci A physical guide that is composed of patient's bony anatomy and allows for precise location of predetermined osteotomy planes and holes.

Device Class : 2

Duns Number: 085049749

Premarket Exempt : No

Product Code : LLZ, DZJ, PPT

Prescription Use : Yes

Device Count : 1

Vantage PSI - 00816847022583 Catalog Number : 351-80-10

Device Class : 2

Duns Number: 085049749

Premarket Exempt : No

Product Code : LLZ, DZJ, PPT

Prescription Use : Yes

Device Count : 1

Vantage PSI - 00816847022590 Catalog Number : 351-80-90

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

Device Class : 2

Duns Number: 085049749

Premarket Exempt : No

Product Code : LLZ, DZJ, PPT

Prescription Use : Yes

Device Count : 1

Vantage PSI - 00816847022606 Catalog Number : 351-80-11

Device Description : Single use stainless steel tube insert to be used for fluoroscopic feedback for Single use stainless steel tube insert to be used for fluoroscopic feedback for alignment of cutting guides.

Device Class : 2

Duns Number: 085049749

Premarket Exempt : No

Product Code : LLZ, DZJ, PPT

Prescription Use : Yes

Device Count : 1

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