| 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 | 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 |
| 3 | 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 |
| 4 | 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 |
| 5 | 03700757200759 | KIT0703 | / | 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 | 00844868040835 | RT-EZTETIC | RADIOGRAPHIC TRANSPARENCY FOR EZTETIC™ DENTAL IMPLANTS | NA | BIOMET 3I, LLC | |
| 2 | 00844868040828 | RT-BTAP | RADIOGRAPHIC TRANSPARENCY FOR BIOMET 3I TAPERED IMPLANTS | NA | BIOMET 3I, LLC | |
| 3 | 00844868040811 | RT-BPW | RADIOGRAPHIC TRANSPARENCY FOR BIOMET 3I PARALLEL WALLED IMPLANTS | NA | BIOMET 3I, LLC | |
| 4 | 00844868040880 | RT-TSV | RADIOGRAPHIC TRANSPARENCY FOR TAPERED SCREW-VENT® IMPLANTS | NA | BIOMET 3I, LLC | |
| 5 | 00844868040873 | RT-SWISSPLT | RADIOGRAPHIC TRANSPARENCY FOR TAPERED SWISSPLUS® IMPLANTS | NA | BIOMET 3I, LLC | |
| 6 | 00844868040842 | RT-SPLINE | RADIOGRAPHIC TRANSPARENCY FOR SPLINE® IMPLANTS | NA | BIOMET 3I, LLC | |
| 7 | 00844868038245 | RT-SHIMP | RADIOGRAPHIC TRANSPARENCY FOR T3® SHORT IMPLANTS | NA | BIOMET 3I, LLC | |
| 8 | 00844856069831 | 87040 | BRIDGE GAUGE | Arsenal | ALPHATEC SPINE, INC. | |
| 9 | 00844856069626 | 87015-500 | 500mm ROD TEMPLATE | Arsenal | ALPHATEC SPINE, INC. | |
| 10 | 00844856069619 | 87015-250 | 250mm ROD TEMPLATE | Arsenal | ALPHATEC SPINE, INC. | |
| 11 | 00844856069602 | 87015-130 | 130mm ROD TEMPLATE | Arsenal | ALPHATEC SPINE, INC. | |
| 12 | 00844856044180 | 73744 | GUIDEWIRE MEASUREMENT RULER | Illico | ALPHATEC SPINE, INC. | |
| 13 | 00844856044104 | 73727 | ROD TEMPLATE | Illico | ALPHATEC SPINE, INC. | |
| 14 | 00844856026780 | 62930-45 | ROD TEMPLATE 45cm LENGTH 5mm DIA | Zodiac | ALPHATEC SPINE, INC. | |
| 15 | 00844856026773 | 62930-15 | ROD TEMPLATE 15cm LENGTH 5mm DIA | Zodiac | ALPHATEC SPINE, INC. | |
| 16 | 00844856007697 | 63924-15 | 3.0mm ROD TEMPLATE, 15cm | Solanas | ALPHATEC SPINE, INC. | |
| 17 | 00844856006072 | 62936 | SCREW MEASUREMENT BLOCK | Zodiac | ALPHATEC SPINE, INC. | |
| 18 | 00843575112552 | 8829P00004 | 8829P00004 | Femoral AR Sizer | AR Specialty Femoral | B-ONE ORTHO, CORP. |
| 19 | 00843575112361 | 8829P00046 | 8829P00046 | Femoral Prep Guide, Long | AR Specialty Femoral | B-ONE ORTHO, CORP. |
| 20 | 00843575112354 | 8829P00045 | 8829P00045 | Femoral Prep Guide, Short | AR Specialty Femoral | B-ONE ORTHO, CORP. |
| 21 | 00843575112347 | 8829P00001 | 8829P00001 | Femoral Prep Guide, Standard | AR Specialty Femoral | B-ONE ORTHO, CORP. |
| 22 | 00843575111043 | 8819000016 | 8819000016 | FEMORAL RESECTION GUIDE | Kosmo Femoral Hip System | B-ONE ORTHO, CORP. |
| 23 | 00843575108708 | 8829102400 | 8829102400 | Adjustable Distal Resection Tower | MOBIO™ Total Knee System | B-ONE ORTHO, CORP. |
| 24 | 00843575108685 | 8829101120 | 8829101120 | Distal Femoral Alignment Guide | MOBIO™ Total Knee System | B-ONE ORTHO, CORP. |
| 25 | 00843575106438 | 8829202000 | 8829202000 | EM Tibial Alignment Guide, Non-Spiked Uprod, Standard | MOBIO™ Total Knee System | B-ONE ORTHO, CORP. |
| 26 | 00843575106421 | 8829201000 | 8829201000 | EM Tibial Alignment Guide, Spiked Uprod, Standard | MOBIO™ Total Knee System | B-ONE ORTHO, CORP. |
| 27 | 00843575104748 | 8829102200 | 8829102200 | Adjustable Distal Resection Guide Tower | MOBIO™ Total Knee System | B-ONE ORTHO, CORP. |
| 28 | 00843575104441 | 8829402000 | 8829402000 | Patella Sizer | MOBIO™ Total Knee System | B-ONE ORTHO, CORP. |
| 29 | 00843575104328 | 8829206000 | 8829206000 | IM Tibial Alignment Guide | MOBIO™ Total Knee System | B-ONE ORTHO, CORP. |
| 30 | 00843575104298 | 8829202100 | 8829202100 | EM Tibial Alignment Guide, Non-Spiked Uprod, Long | MOBIO™ Total Knee System | B-ONE ORTHO, CORP. |
| 31 | 00843575104281 | 8829201100 | 8829201100 | EM Tibial Alignment Guide, Spiked Uprod, Long | MOBIO™ Total Knee System | B-ONE ORTHO, CORP. |
| 32 | 00843575104274 | 8829200000 | 8829200000 | EM Tibial Alignment Guide, Base | MOBIO™ Total Knee System | B-ONE ORTHO, CORP. |
| 33 | 00843575104243 | 8829102000 | 8829102000 | Fixed Distal Resection Guide Tower | MOBIO™ Total Knee System | B-ONE ORTHO, CORP. |
| 34 | 00843575104236 | 8829101200 | 8829101200 | Epicondylar Guide | MOBIO™ Total Knee System | B-ONE ORTHO, CORP. |
| 35 | 00843575104229 | 8829101100 | 8829101100 | Distal Femoral Alignment Guide | MOBIO™ Total Knee System | B-ONE ORTHO, CORP. |
| 36 | 00843575104106 | 881906436L | 881906436L | ACETABULAR LINER TRIAL, HOODED, 10 degree, SIZE L X 36MM I.D. | b-ONE™ Primary Acetabular System | B-ONE ORTHO, CORP. |
| 37 | 00843575104090 | 881906436K | 881906436K | ACETABULAR LINER TRIAL, HOODED, 10 degree, SIZE K X 36MM I.D. | b-ONE™ Primary Acetabular System | B-ONE ORTHO, CORP. |
| 38 | 00843575104083 | 881906436J | 881906436J | ACETABULAR LINER TRIAL, HOODED, 10 degree, SIZE J X 36MM I.D. | b-ONE™ Primary Acetabular System | B-ONE ORTHO, CORP. |
| 39 | 00843575104076 | 881906436I | 881906436I | ACETABULAR LINER TRIAL, HOODED, 10 degree, SIZE I X 36MM I.D. | b-ONE™ Primary Acetabular System | B-ONE ORTHO, CORP. |
| 40 | 00843575104069 | 881906432I | 881906432I | ACETABULAR LINER TRIAL, HOODED, 10 degree, SIZE I X 32MM I.D. | b-ONE™ Primary Acetabular System | B-ONE ORTHO, CORP. |
| 41 | 00843575104052 | 881906436H | 881906436H | ACETABULAR LINER TRIAL, HOODED, 10 degree, SIZE H X 36MM I.D. | b-ONE™ Primary Acetabular System | B-ONE ORTHO, CORP. |
| 42 | 00843575104045 | 881906432H | 881906432H | ACETABULAR LINER TRIAL, HOODED, 10 degree, SIZE H X 32MM I.D. | b-ONE™ Primary Acetabular System | B-ONE ORTHO, CORP. |
| 43 | 00843575104038 | 881906436G | 881906436G | ACETABULAR LINER TRIAL, HOODED, 10 degree, SIZE G X 36MM I.D. | b-ONE™ Primary Acetabular System | B-ONE ORTHO, CORP. |
| 44 | 00843575104021 | 881906432G | 881906432G | ACETABULAR LINER TRIAL, HOODED, 10 degree, SIZE G X 32MM I.D. | b-ONE™ Primary Acetabular System | B-ONE ORTHO, CORP. |
| 45 | 00843575104014 | 881906428G | 881906428G | ACETABULAR LINER TRIAL, HOODED, 10 degree, SIZE G X 28MM I.D. | b-ONE™ Primary Acetabular System | B-ONE ORTHO, CORP. |
| 46 | 00843575104007 | 881906432F | 881906432F | ACETABULAR LINER TRIAL, HOODED, 10 degree, SIZE F X 32MM I.D. | b-ONE™ Primary Acetabular System | B-ONE ORTHO, CORP. |
| 47 | 00843575103994 | 881906428F | 881906428F | ACETABULAR LINER TRIAL, HOODED, 10 degree, SIZE F X 28MM I.D. | b-ONE™ Primary Acetabular System | B-ONE ORTHO, CORP. |
| 48 | 00843575103987 | 881906432E | 881906432E | ACETABULAR LINER TRIAL, HOODED, 10 degree, SIZE E X 32MM I.D. | b-ONE™ Primary Acetabular System | B-ONE ORTHO, CORP. |
| 49 | 00843575103970 | 881906428E | 881906428E | ACETABULAR LINER TRIAL, HOODED, 10 degree, SIZE E X 28MM I.D. | b-ONE™ Primary Acetabular System | B-ONE ORTHO, CORP. |
| 50 | 00843575103963 | 881906428D | 881906428D | ACETABULAR LINER TRIAL, HOODED, 10 degree, SIZE D X 28MM I.D. | b-ONE™ Primary Acetabular System | B-ONE ORTHO, CORP. |