| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 03700757200803 | KIT0708 | / | spineEOS rod template is intended to be designed from patient’s imaging data (EO spineEOS rod template is intended to be designed from patient’s imaging data (EOS images) in order to obtain a patient specific template, which allows to reproduce the shape of the planned spinal rods during surgery. Preoperative planning is performed and validated by surgeon with spineEOS software (provide a preoperative planning solution for spine surgeries). The template is designed from the output data of the software.This device is intended for guiding the surgeon during the bending of rods for spinal arthrodesis. However, in this context, the surgeon is the only one to determine whether patients can benefit from this technology according to his habits and his | HWT | Template | 1 | spineEOS rod Template |
| 2 | 03700757200797 | KIT0707 | / | spineEOS rod template is intended to be designed from patient’s imaging data (EO spineEOS rod template is intended to be designed from patient’s imaging data (EOS images) in order to obtain a patient specific template, which allows to reproduce the shape of the planned spinal rods during surgery. Preoperative planning is performed and validated by surgeon with spineEOS software (provide a preoperative planning solution for spine surgeries). The template is designed from the output data of the software.This device is intended for guiding the surgeon during the bending of rods for spinal arthrodesis. However, in this context, the surgeon is the only one to determine whether patients can benefit from this technology according to his habits and his surgical experience. | HWT | Template | 1 | spineEOS rod Template |
| 3 | 03700757200780 | KIT0706 | / | spineEOS rod template is intended to be designed from patient’s imaging data (EO spineEOS rod template is intended to be designed from patient’s imaging data (EOS images) in order to obtain a patient specific template, which allows to reproduce the shape of the planned spinal rods during surgery. Preoperative planning is performed and validated by surgeon with spineEOS software (provide a preoperative planning solution for spine surgeries). The template is designed from the output data of the software.This device is intended for guiding the surgeon during the bending of rods for spinal arthrodesis. However, in this context, the surgeon is the only one to determine whether patients can benefit from this technology according to his habits and his surgical experience. | HWT | Template | 1 | spineEOS rod Template |
| 4 | 03700757200773 | KIT0705 | / | spineEOS rod template is intended to be designed from patient’s imaging data (EO spineEOS rod template is intended to be designed from patient’s imaging data (EOS images) in order to obtain a patient specific template, which allows to reproduce the shape of the planned spinal rods during surgery. Preoperative planning is performed and validated by surgeon with spineEOS software (provide a preoperative planning solution for spine surgeries). The template is designed from the output data of the software.This device is intended for guiding the surgeon during the bending of rods for spinal arthrodesis. However, in this context, the surgeon is the only one to determine whether patients can benefit from this technology according to his habits and his surgical experience. | HWT | Template | 1 | spineEOS rod Template |
| 5 | 03700757200766 | KIT0704 | / | spineEOS rod template is intended to be designed from patient’s imaging data (EO spineEOS rod template is intended to be designed from patient’s imaging data (EOS images) in order to obtain a patient specific template, which allows to reproduce the shape of the planned spinal rods during surgery. Preoperative planning is performed and validated by surgeon with spineEOS software (provide a preoperative planning solution for spine surgeries). The template is designed from the output data of the software.This device is intended for guiding the surgeon during the bending of rods for spinal arthrodesis. However, in this context, the surgeon is the only one to determine whether patients can benefit from this technology according to his habits and his surgical experience. | HWT | Template | 1 | spineEOS rod Template |
| 6 | 03700757200650 | KIT0702 | / | spineEOS rod template is intended to be designed from patient’s imaging data (EO spineEOS rod template is intended to be designed from patient’s imaging data (EOS images) in order to obtain a patient specific template, which allows to reproduce the shape of the planned spinal rods during surgery. Preoperative planning is performed and validated by surgeon with spineEOS software (provide a preoperative planning solution for spine surgeries). The template is designed from the output data of the software.This device is intended for guiding the surgeon during the bending of rods for spinal arthrodesis. However, in this context, the surgeon is the only one to determine whether patients can benefit from this technology according to his habits and his surgical experience. | HWT | Template | 1 | spineEOS rod Template |
| 7 | 03700757200643 | KIT0701 | / | spineEOS rod template is intended to be designed from patient’s imaging data (EO spineEOS rod template is intended to be designed from patient’s imaging data (EOS images) in order to obtain a patient specific template, which allows to reproduce the shape of the planned spinal rods during surgery. Preoperative planning is performed and validated by surgeon with spineEOS software (provide a preoperative planning solution for spine surgeries). The template is designed from the output data of the software.This device is intended for guiding the surgeon during the bending of rods for spinal arthrodesis. However, in this context, the surgeon is the only one to determine whether patients can benefit from this technology according to his habits and his surgical experience. | HWT | Template | 1 | spineEOS rod Template |
| 8 | 03700757200858 | 1.x | spineEOS 1.x allows surgeons to perform preoperative surgical planning of spine spineEOS 1.x allows surgeons to perform preoperative surgical planning of spine surgeries in case of Adolescent Idiopathic Scoliosis (AIS) or deformative/degenerative spine. The software provides surgical tools for the correction of the curvature, for the placement of cages and for the achievement of osteotomies. | LLZ | System, Image Processing, Radiological | 2 | spineEOS | |
| 9 | 03700757200544 | 1.1 | spineEOS allows surgeons to perform preoperative surgical planning of spine surg spineEOS allows surgeons to perform preoperative surgical planning of spine surgeries in case of Adolescent Idiopathic Scoliosis (AIS) or deformative/degenerative spine. The software provides surgical tools for the correction of the curvature, for the placement of cages and for the achievement of osteotomies. | LLZ | System, Image Processing, Radiological | 2 | spineEOS | |
| 10 | 03700757200834 | 3.x | hipEOS allows surgeons to perform pre-operative surgical planning for hip replac hipEOS allows surgeons to perform pre-operative surgical planning for hip replacement. The program features an extensive regularly updated library of digital 3D models of implants form leading implant manufacturers. It allows the overlay of the 3D/2D implant models on the radiological images and on the 3D reconstruction and permits the selection of appropriate size and position of implant. | LLZ | System, Image Processing, Radiological | 2 | hipEOS | |
| 11 | 03700757200827 | 2.x | / | hipEOS allows surgeons to perform pre-operative surgical planning for hip replac hipEOS allows surgeons to perform pre-operative surgical planning for hip replacement. The program features an extensive regularly updated library of digital 3D models of implants form leading implant manufacturers. It allows the overlay of the 3D/2D implant models on the radiological images and on the 3D reconstruction and permits the selection of appropriate size and position of implant. | LLZ | System, Image Processing, Radiological | 2 | hipEOS |
| 12 | 03700757200520 | 2.5 | hipEOS allows surgeons to perform pre-operative surgical planning for hip replac hipEOS allows surgeons to perform pre-operative surgical planning for hip replacement. The program features an extensive regularly updated library of digital 3D models of implants form leading implant manufacturers. It allows the overlay of the 3D/2D implant models on the radiological images and on the 3D reconstruction and permits the selection of appropriate size and position of implant. | LLZ | System, Image Processing, Radiological | 2 | hipEOS | |
| 13 | 03700757200506 | 1.0 | kneeEOS allows surgeons to perform preoperative surgical planning of total kneea kneeEOS allows surgeons to perform preoperative surgical planning of total kneearthroplasties. The software provides surgical tools to analyze preoperative data, to set the resection levels, to position and size the femoral and tibial components and to evaluate the final alignment of the leg. | LLZ | System, Image Processing, Radiological | 2 | kneeEOS |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 10889987163574 | SR-034512 | SR-034512 | Trial w/o stop 16x14x12mm, 7 Deg | Specials | SEASPINE ORTHOPEDICS CORPORATION |
| 2 | 10889987163567 | SR-034511 | SR-034511 | Trial w/o stop 16x14x11mm, 7 Deg | Specials | SEASPINE ORTHOPEDICS CORPORATION |
| 3 | 10889987163550 | SR-034510 | SR-034510 | Trial w/o stop 16x14x10mm, 7 Deg | Specials | SEASPINE ORTHOPEDICS CORPORATION |
| 4 | 10889987163543 | SR-034509 | SR-034509 | Trial w/o stop 16x14x09mm, 7 Deg | Specials | SEASPINE ORTHOPEDICS CORPORATION |
| 5 | 10889987163536 | SR-034508 | SR-034508 | Trial w/o stop 16x14x08mm, 7 Deg | Specials | SEASPINE ORTHOPEDICS CORPORATION |
| 6 | 10889987163529 | SR-034507 | SR-034507 | Trial w/o stop 16x14x07mm, 7 Deg | Specials | SEASPINE ORTHOPEDICS CORPORATION |
| 7 | 10889987163512 | SR-034506 | SR-034506 | Trial w/o stop 16x14x06mm, 7 Deg | Specials | SEASPINE ORTHOPEDICS CORPORATION |
| 8 | 10889987163505 | SR-034505 | SR-034505 | Trial w/o stop 16x14x05mm, 7 Deg | Specials | SEASPINE ORTHOPEDICS CORPORATION |
| 9 | 10889987163345 | 90-3012 | 90-3012 | 5.5mm X 500mm Rod Template | Mariner | SEASPINE ORTHOPEDICS CORPORATION |
| 10 | 10889981302320 | SR-0889-2313-10 | SR-0889-2313-10 | Lollipop Trial, Anterior-Angled, 23mm x 13mm x 55mm, 10° | Specials | SEASPINE ORTHOPEDICS CORPORATION |
| 11 | 10889981302313 | SR-0889-2311-10 | SR-0889-2311-10 | Lollipop Trial, Anterior-Angled, 23mm x 11mm x 55mm, 10° | Specials | SEASPINE ORTHOPEDICS CORPORATION |
| 12 | 10889981302306 | SR-0889-2309-10 | SR-0889-2309-10 | Lollipop Trial, Anterior-Angled, 23mm x 9mm x 55mm, 10° | Specials | SEASPINE ORTHOPEDICS CORPORATION |
| 13 | 10889981302290 | SR-0889-2307-10 | SR-0889-2307-10 | Lollipop Trial, Anterior-Angled, 23mm x 7mm x 55mm, 10° | Specials | SEASPINE ORTHOPEDICS CORPORATION |
| 14 | 10889981302283 | SR-0889-2305-05 | SR-0889-2305-05 | Lollipop Trial, Anterior-Angled, 23mm x 5mm x 55mm, 5° | Specials | SEASPINE ORTHOPEDICS CORPORATION |
| 15 | 10889981301064 | SR-0891-1813-10 | SR-0891-1813-10 | Lollipop Trial, Right/Down-Angled, 18mm x 13mm x 55mm, 10° | Specials | SEASPINE ORTHOPEDICS CORPORATION |
| 16 | 10889981301057 | SR-0891-1811-10 | SR-0891-1811-10 | Lollipop Trial, Right/Down-Angled, 18mm x 11mm x 55mm, 10° | Specials | SEASPINE ORTHOPEDICS CORPORATION |
| 17 | 10889981301040 | SR-0891-1809-10 | SR-0891-1809-10 | Lollipop Trial, Right/Down-Angled, 18mm x 9mm x 55mm, 10° | Specials | SEASPINE ORTHOPEDICS CORPORATION |
| 18 | 10889981301033 | SR-0891-1807-10 | SR-0891-1807-10 | Lollipop Trial, Right/Down-Angled, 18mm x 7mm x 55mm, 10° | Specials | SEASPINE ORTHOPEDICS CORPORATION |
| 19 | 10889981301026 | SR-0891-1805-10 | SR-0891-1805-10 | Lollipop Trial, Right/Down-Angled, 18mm x 5mm x 55mm, 10° | Specials | SEASPINE ORTHOPEDICS CORPORATION |
| 20 | 10889981301019 | SR-0890-1813-10 | SR-0890-1813-10 | Lollipop Trial, Right/Up-Angled, 18mm x 13mm x 55mm, 10° | Specials | SEASPINE ORTHOPEDICS CORPORATION |
| 21 | 10889981301002 | SR-0890-1811-10 | SR-0890-1811-10 | Lollipop Trial, Right/Up-Angled, 18mm x 11mm x 55mm, 10° | Specials | SEASPINE ORTHOPEDICS CORPORATION |
| 22 | 10889981300999 | SR-0890-1809-10 | SR-0890-1809-10 | Lollipop Trial, Right/Up-Angled, 18mm x 9mm x 55mm, 10° | Specials | SEASPINE ORTHOPEDICS CORPORATION |
| 23 | 10889981300982 | SR-0890-1807-10 | SR-0890-1807-10 | Lollipop Trial, Right/Up-Angled, 18mm x 7mm x 55mm, 10° | Specials | SEASPINE ORTHOPEDICS CORPORATION |
| 24 | 10889981300975 | SR-0890-1805-10 | SR-0890-1805-10 | Lollipop Trial, Right/Up-Angled, 18mm x 5mm x 55mm, 10° | Specials | SEASPINE ORTHOPEDICS CORPORATION |
| 25 | 10889981300968 | SR-0889-1813-10 | SR-0889-1813-10 | Lollipop Trial, Anterior-Angled, 18mm x 13mm x 55mm, 10° | Specials | SEASPINE ORTHOPEDICS CORPORATION |
| 26 | 10889981300951 | SR-0889-1811-10 | SR-0889-1811-10 | Lollipop Trial, Anterior-Angled, 18mm x 11mm x 55mm, 10° | Specials | SEASPINE ORTHOPEDICS CORPORATION |
| 27 | 10889981300944 | SR-0889-1809-10 | SR-0889-1809-10 | Lollipop Trial, Anterior-Angled, 18mm x 9mm x 55mm, 10° | Specials | SEASPINE ORTHOPEDICS CORPORATION |
| 28 | 10889981300937 | SR-0889-1807-10 | SR-0889-1807-10 | Lollipop Trial, Anterior-Angled, 18mm x 7mm x 55mm, 10° | Specials | SEASPINE ORTHOPEDICS CORPORATION |
| 29 | 10889981300920 | SR-0889-1805-10 | SR-0889-1805-10 | Lollipop Trial, Anterior-Angled, 18mm x 5mm x 55mm, 10° | Specials | SEASPINE ORTHOPEDICS CORPORATION |
| 30 | 10889981298517 | SR-0851 | SR-0851 | Disc Wedge, Small Footprint | Specials | SEASPINE ORTHOPEDICS CORPORATION |
| 31 | 10889981291167 | SR-0816 | SR-0816 | Starter Trial, 31 x 24 x 6, 15 Deg | Specials | SEASPINE ORTHOPEDICS CORPORATION |
| 32 | 10889981289294 | ET2-102112 | ET2-102112 | 12mm Trial, 11mm Height | Explorer TO | SEASPINE ORTHOPEDICS CORPORATION |
| 33 | 10889981289287 | ET2-102110 | ET2-102110 | 10mm Trial, 11mm Height | Explorer TO | SEASPINE ORTHOPEDICS CORPORATION |
| 34 | 10889981289270 | ET2-102108 | ET2-102108 | 8mm Trial, 11mm Height | Explorer TO | SEASPINE ORTHOPEDICS CORPORATION |
| 35 | 10889981285869 | 86-1112 | 86-1112 | Trial 16x12x12mm, 7 Deg Lordosis, w/ Depth Stop | Shoreline ACS | SEASPINE ORTHOPEDICS CORPORATION |
| 36 | 10889981285852 | 86-1111 | 86-1111 | Trial 16x12x11mm, 7 Deg Lordosis, w/ Depth Stop | Shoreline ACS | SEASPINE ORTHOPEDICS CORPORATION |
| 37 | 10889981285845 | 86-1110 | 86-1110 | Trial 16x12x10mm, 7 Deg Lordosis, w/ Depth Stop | Shoreline ACS | SEASPINE ORTHOPEDICS CORPORATION |
| 38 | 10889981285838 | 86-1109 | 86-1109 | Trial 16x12x9mm, 7 Deg Lordosis, w/ Depth Stop | Shoreline ACS | SEASPINE ORTHOPEDICS CORPORATION |
| 39 | 10889981285821 | 86-1108 | 86-1108 | Trial 16x12x8mm, 7 Deg Lordosis, w/ Depth Stop | Shoreline ACS | SEASPINE ORTHOPEDICS CORPORATION |
| 40 | 10889981285814 | 86-1107 | 86-1107 | Trial 16x12x7mm, 7 Deg Lordosis, w/ Depth Stop | Shoreline ACS | SEASPINE ORTHOPEDICS CORPORATION |
| 41 | 10889981285807 | 86-1106 | 86-1106 | Trial 16x12x6mm, 7 Deg Lordosis, w/ Depth Stop | Shoreline ACS | SEASPINE ORTHOPEDICS CORPORATION |
| 42 | 10889981285791 | 86-1105 | 86-1105 | Trial 16x12x5mm, 7 Deg Lordosis, w/ Depth Stop | Shoreline ACS | SEASPINE ORTHOPEDICS CORPORATION |
| 43 | 10889981284510 | RA2-006015 | RA2-006015 | Anterior Plate Sizing Trial Tip | Meridian | SEASPINE ORTHOPEDICS CORPORATION |
| 44 | 10889981277253 | AP2-101412 | AP2-101412 | Modular Trial, 14 x 13 x 12mm, 7 Deg Lordosis | Admiral | SEASPINE ORTHOPEDICS CORPORATION |
| 45 | 10889981277246 | AP2-101411 | AP2-101411 | Modular Trial, 14 x 13 x 11mm, 7 Deg Lordosis | Admiral | SEASPINE ORTHOPEDICS CORPORATION |
| 46 | 10889981277239 | AP2-101410 | AP2-101410 | Modular Trial, 14 x 13 x 10mm, 7 Deg Lordosis | Admiral | SEASPINE ORTHOPEDICS CORPORATION |
| 47 | 10889981277222 | AP2-101409 | AP2-101409 | Modular Trial, 14 x 13 x 9mm, 7 Deg Lordosis | Admiral | SEASPINE ORTHOPEDICS CORPORATION |
| 48 | 10889981277215 | AP2-101408 | AP2-101408 | Modular Trial, 14 x 13 x 8mm, 7 Deg Lordosis | Admiral | SEASPINE ORTHOPEDICS CORPORATION |
| 49 | 10889981277208 | AP2-101407 | AP2-101407 | Modular Trial, 14 x 13 x 7mm, 7 Deg Lordosis | Admiral | SEASPINE ORTHOPEDICS CORPORATION |
| 50 | 10889981277192 | AP2-101406 | AP2-101406 | Modular Trial, 14 x 13 x 6mm, 7 Deg Lordosis | Admiral | SEASPINE ORTHOPEDICS CORPORATION |