Cadence Ankle PSI System
3D Systems, Inc.
3D SYSTEMS, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1000263603 | 1000263603 | 3D SYSTEMS, INC. | 1 | Y | 2026-01-01 | 321 Three D Systems Circle Rock Hill SC US 29730 |
| 3010705004 | 3010705004 | 3D SYSTEMS - LAYERWISE | 1 | N | 2026-01-01 | Grauwmeer 14 Heverlee Vlaams Brabant BE 3001 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 179189 | 1494145464 | K170503 | EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular Titanium TLIF Cages, and EIT Cellular Titanium ALIF Cages | MAX | 2017-07-11 |
| 179189 | 1255078388 | K170318 | NeoFuse Ti3D PLIF/TLIF/Cervical Interbody | ODP | 2017-07-12 |
| 179189 | 1256765332 | K162264 | Cascadia Interbody System | MAX | 2016-09-21 |
| 179189 | 1471299350 | K160547 | Cascadia Interbody System | MAX | 2016-03-24 |
| 179189 | 1891409911 | K160125 | Cascadia Interbody System | ODP | 2016-04-22 |
| 179189 | 2052010562 | K150481 | Cascadia Interbody System | MAX | 2015-08-20 |
| 179189 | 1236958546 | K141405 | MOBIS II ST SPINAL IMPLANT | MAX | 2014-09-16 |
| 179189 | 1154533438 | K091051 | BOLLARD MINIPLATE SKELETAL ANCHORAGE SYSTEM | DZE | 2009-12-08 |
| 179189 | 1033165166 | ||||
| 179189 | 1034477360 | ||||
| 179189 | 1089901533 | ||||
| 179189 | 1141746220 | ||||
| 179189 | 1154533438 | ||||
| 179189 | 1167697046 | ||||
| 179189 | 1187622652 | ||||
| 179189 | 1236958546 | ||||
| 179189 | 1255078388 | ||||
| 179189 | 1256765332 | ||||
| 179189 | 1289532956 | ||||
| 179189 | 1291677264 | ||||
| 179189 | 1365122662 | ||||
| 179189 | 1446851742 | ||||
| 179189 | 1469159556 | ||||
| 179189 | 1471299350 | ||||
| 179189 | 1494145464 | ||||
| 179189 | 1510705757 | ||||
| 179189 | 1803212238 | ||||
| 179189 | 1817721274 | ||||
| 179189 | 1821306785 | ||||
| 179189 | 1863779490 | ||||
| 179189 | 1871987290 | ||||
| 179189 | 1880509759 | ||||
| 179189 | 1891409911 | ||||
| 179189 | 1901344439 | ||||
| 179189 | 1908199880 | ||||
| 179189 | 1940000719 | ||||
| 179189 | 1965575346 | ||||
| 179189 | 1985853521 | ||||
| 179189 | 2052010562 |
Product Codes Associated With Registrations#
PMN#
Salto Talaris Ankle PSI System
3D Systems, Inc.
Salto Talaris Ankle PSI System
3D Systems, Inc.
Cadence Ankle PSI System
3D Systems, Inc.
VSP PEEK Cranial Implant
3D Systems, Inc.
Vantage PSI System
3D Systems, Inc.
VSP Bolus
3D Systems
VSP® Orthopedics System
3D Systems
VSP System
3D Systems
Vantage PSI System
3D Systems
VSP System
3D Systems
D2P
3D Systems, Inc.
VSP Orthopedics System
3D Systems, Inc.
D2P
3D SYSTEMS, INC.
VSP Cranial System
3D Systems, Inc.
GUDID#
VSP PEEK - provided as a guide , to determine the orientation and examine the fitment of the implant on the cranial defect prior to surgery
2025-11-10
Salto Talaris Flat Cut Total Ankle System - A physical guide that is composed of patient's bony anatomy and allows for precise location of predetermined osteotomy planes and holes.
2025-01-10
Salto Talaris Flat Cut Total Ankle System - A physical guide that is composed of patient's bony anatomy and allows for precise location of predetermined osteotomy planes and holes.
2025-01-10
Salto Talaris Flat Cut Total Ankle System - 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.
2025-01-10
Cadence Flat Cut Total Ankle System - A physical guide that is composed of patient's bony anatomy and allows for precise location of predetermined osteotomy planes and holes.
2025-01-10
Cadence Flat Cut Total Ankle System - A physical guide that is composed of patient's bony anatomy and allows for precise location of predetermined osteotomy planes and holes.
2025-01-10
Cadence Flat Cut Total Ankle System - 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.
2025-01-10
Cadence Chamfer Cut Total Ankle System - 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.
2024-09-12
Salto Talaris Chamfer Cut Total Ankle System - 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.
2024-09-12
VSP PEEK - to fill a bony void or defect area in the cranial skeleton of patients
2024-09-12
Salto Talaris Chamfer Cut Total Ankle System - A physical guide that is composed of patient's bony anatomy and allows for precise location of predetermined osteotomy planes and holes.
2024-09-12
Salto Talaris Chamfer Cut Total Ankle System - A physical guide that is composed of patient's bony anatomy and allows for precise location of predetermined osteotomy planes and holes
2024-09-12
Cadence Chamfer Cut Total Ankle System - A physical guide that is composed of patient's bony anatomy and allows for precise location of predetermined osteotomy planes and holes.
2024-09-12
Cadence Chamfer Cut Total Ankle System - A physical guide that is composed of patient's bony anatomy and allows for precise location of predetermined osteotomy planes and holes
2024-09-12
Vantage 3D PSI - A physical guide that is composed of patient's bony anatomy and allows for precise location of predetermined osteotomy planes and holes
2024-08-05
Vantage 3D PSI - A physical guide that is composed of patient's bony anatomy and allows for precise location of predetermined osteotomy planes and holes.
2024-08-05
Vantage 3D PSI - 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.
2024-08-05
Vantage 3D+ PSI - A physical guide that is composed of patient's bony anatomy and allows for precise location of predetermined osteotomy planes and holes.
2024-08-05
Vantage 3D+ PSI - A physical guide that is composed of patient's bony anatomy and allows for precise location of predetermined osteotomy planes and holes.
2024-08-05
Vantage 3D+ PSI - 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.
2024-08-05
Vantage PSI - A physical guide that is composed of patient's bony anatomy and allows for precise location of predetermined osteotomy planes and holes.
2020-11-13
Vantage PSI - A physical guide that is composed of patient's bony anatomy and allows for precise location of predetermined osteotomy planes and holes.
2020-11-13
Vantage PSI - 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.
2020-11-13
VSP System - 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.
2016-09-12
VSP System, VSP Cranial - 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.
2016-10-12
VSP System, VSP Cranial - 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.
2016-10-12
VSP System - 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.
2016-09-12
VSP System - 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.
2016-09-12
VSP System - 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.
2016-09-12
VSP System - 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.
2016-09-12
VSP System, VSP Cranial - 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.
2016-09-12
VSP System - 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.
2016-09-12
VSP System - 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.
2016-09-12
VSP System, VSP Cranial - 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.
2016-09-12
VSP System, VSP Cranial - 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.
2016-09-12
VSP System - 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.
2016-09-12
VSP System - 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.
2016-09-12
VSP System, VSP Cranial - 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.
2016-09-12
VSP System - 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.
2016-09-12
VSP System - 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.
2016-09-12