No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00817577023802 | A | 2000-7029 | Syndesmosis Plate | HRS | Plate, Fixation, Bone | 2 | EPIC FRACTURE PLATE SYSTEM |
2 | 00817577023796 | A | 2000-7028 | Straight Plate Contoured - 14 Hole | HRS | Plate, Fixation, Bone | 2 | EPIC FRACTURE PLATE SYSTEM |
3 | 00817577024823 | A | 2100-7001 | Medial Hook Plate Drill Guide | HRS | Plate, Fixation, Bone | 2 | EPIC FRACTURE PLATE SYSTEM |
4 | 00817577024816 | A | 2100-7000 | Medial Hook Plate Impactor | HRS | Plate, Fixation, Bone | 2 | EPIC FRACTURE PLATE SYSTEM |
5 | 00817577024342 | A | 2001-4060 | 4.0mm Non-Locking Screw x 60mm | HRS | Plate, Fixation, Bone | 2 | EPIC FRACTURE PLATE SYSTEM |
6 | 00817577024311 | A | 2001-4055 | 4.0mm Non-Locking Screw x 55mm | HRS | Plate, Fixation, Bone | 2 | EPIC FRACTURE PLATE SYSTEM |
7 | 00817577024281 | A | 2001-4050 | 4.0mm Non-Locking Screw x 50mm | HRS | Plate, Fixation, Bone | 2 | EPIC FRACTURE PLATE SYSTEM |
8 | 00817577024250 | A | 2001-4045 | 4.0mm Non-Locking Screw x 45mm | HRS | Plate, Fixation, Bone | 2 | EPIC FRACTURE PLATE SYSTEM |
9 | 00817577023789 | A | 2000-7027 | Straight Plate Contoured - 12 Hole | HRS | Plate, Fixation, Bone | 2 | EPIC FRACTURE PLATE SYSTEM |
10 | 00817577023772 | A | 2000-7026 | Straight Plate Contoured - 10 Hole | HRS | Plate, Fixation, Bone | 2 | EPIC FRACTURE PLATE SYSTEM |
11 | 00817577023765 | A | 2000-7025 | Straight Plate Contoured - 8 Hole | HRS | Plate, Fixation, Bone | 2 | EPIC FRACTURE PLATE SYSTEM |
12 | 00817577023758 | A | 2000-7024 | Straight Plate Contoured - 6 Hole | HRS | Plate, Fixation, Bone | 2 | EPIC FRACTURE PLATE SYSTEM |
13 | 00817577023741 | A | 2000-7023 | Universal Recon Plate - 17 Hole | HRS | Plate, Fixation, Bone | 2 | EPIC FRACTURE PLATE SYSTEM |
14 | 00817577023734 | A | 2000-7022 | Universal Recon Plate - 15 Hole | HRS | Plate, Fixation, Bone | 2 | EPIC FRACTURE PLATE SYSTEM |
15 | 00817577023727 | A | 2000-7021 | Universal Recon Plate - 13 Hole | HRS | Plate, Fixation, Bone | 2 | EPIC FRACTURE PLATE SYSTEM |
16 | 00817577023710 | A | 2000-7020 | Universal Recon Plate - 11 Hole | HRS | Plate, Fixation, Bone | 2 | EPIC FRACTURE PLATE SYSTEM |
17 | 00817577023703 | A | 2000-7019 | Universal Recon Plate - 9 Hole | HRS | Plate, Fixation, Bone | 2 | EPIC FRACTURE PLATE SYSTEM |
18 | 00817577023697 | A | 2000-7018 | Straight Plate - 14 Hole | HRS | Plate, Fixation, Bone | 2 | EPIC FRACTURE PLATE SYSTEM |
19 | 00817577023680 | A | 2000-7017 | Straight Plate - 12 Hole | HRS | Plate, Fixation, Bone | 2 | EPIC FRACTURE PLATE SYSTEM |
20 | 00817577023673 | A | 2000-7016 | Straight Plate - 10 Hole | HRS | Plate, Fixation, Bone | 2 | EPIC FRACTURE PLATE SYSTEM |
21 | 00817577023666 | A | 2000-7015 | Straight Plate - 8 Hole | HRS | Plate, Fixation, Bone | 2 | EPIC FRACTURE PLATE SYSTEM |
22 | 00817577023659 | A | 2000-7014 | Straight Plate - 6 Hole | HRS | Plate, Fixation, Bone | 2 | EPIC FRACTURE PLATE SYSTEM |
23 | 00817577023642 | A | 2000-7013 | Posterior Plate - Long | HRS | Plate, Fixation, Bone | 2 | EPIC FRACTURE PLATE SYSTEM |
24 | 00817577023635 | A | 2000-7012 | Posterior Plate - Std | HRS | Plate, Fixation, Bone | 2 | EPIC FRACTURE PLATE SYSTEM |
25 | 00817577023628 | B | 2000-7011 | Left Lateral Fibula Plate - Xlong | HRS | Plate, Fixation, Bone | 2 | EPIC FRACTURE PLATE SYSTEM |
26 | 00817577023611 | B | 2000-7010 | Left Lateral Fibula Plate - Long | HRS | Plate, Fixation, Bone | 2 | EPIC FRACTURE PLATE SYSTEM |
27 | 00817577023604 | B | 2000-7009 | Left Lateral Fibula Plate - STD | HRS | Plate, Fixation, Bone | 2 | EPIC FRACTURE PLATE SYSTEM |
28 | 00817577023598 | B | 2000-7008 | Right Lateral Fibula Plate - XLong | HRS | Plate, Fixation, Bone | 2 | EPIC FRACTURE PLATE SYSTEM |
29 | 00817577023581 | B | 2000-7007 | Right Lateral Fibula Plate - Long | HRS | Plate, Fixation, Bone | 2 | EPIC FRACTURE PLATE SYSTEM |
30 | 00817577023574 | B | 2000-7006 | Right Lateral Fibula Plate - Std | HRS | Plate, Fixation, Bone | 2 | EPIC FRACTURE PLATE SYSTEM |
31 | 00817577023567 | B | 2000-7005 | Universal Lateral Fibula Plate - XLong | HRS | Plate, Fixation, Bone | 2 | EPIC FRACTURE PLATE SYSTEM |
32 | 00817577023550 | B | 2000-7004 | Universal Lateral Fibula Plate - Long | HRS | Plate, Fixation, Bone | 2 | EPIC FRACTURE PLATE SYSTEM |
33 | 00817577023543 | B | 2000-7003 | HRS | Plate, Fixation, Bone | 2 | EPIC FRACTURE PLATE SYSTEM | |
34 | 00817577023536 | A | 2000-7002 | HRS | Plate, Fixation, Bone | 2 | EPIC FRACTURE PLATE SYSTEM | |
35 | 00817577023529 | A | 2000-7001 | HRS | Plate, Fixation, Bone | 2 | EPIC FRACTURE PLATE SYSTEM | |
36 | 00817577023512 | 1100-0005 | 1100-0005 | RATCHET HANDLE, LARGE | HXX | SCREWDRIVER | 1 | NA |
37 | 00817577023505 | 1100-0004 | 1100-0004 | RATCHET HANDLE, SMALL | HXX | SCREWDRIVER | 1 | NA |
38 | 00817577023208 | 4100-0001 | 4100-0001 | SNAP-OFF DRIVER | HWC | Screw, fixation, bone | 2 | NA |
39 | 00817577023130 | 2100-2700 | 2100-2700 | 2.7MM SOLID DRILL BIT | HRS | Plate, fixation, bone | 2 | NA |
40 | 00817577022898 | 2100-2009 | 2100-2009 | SPREADER (OPENING WEDGE) | LXH | Orthopedic manual surgical instrument | 1 | NA |
41 | 00817577022881 | 2100-2027 | 2100-2027 | 2.0/2.7DOUBLEENDE DRILLGUIDE | HRS | Plate, fixation, bone | 2 | NA |
42 | 00817577022874 | 2100-2000 | 2100-2000 | 2.0MM SOLID DRILL BIT | HRS | Plate, fixation, bone | 2 | NA |
43 | 00817577022867 | 2100-1023 | 2100-1023 | 22MM CONE REAMER | HTO | REAMER | 1 | NA |
44 | 00817577022850 | 2100-1022 | 2100-1022 | 22MM CUP REAMER | HTO | REAMER | 1 | NA |
45 | 00817577022843 | 2100-1021 | 2100-1021 | 20MM CONE REAMER | HTO | REAMER | 1 | NA |
46 | 00817577022836 | 2100-1020 | 2100-1020 | 20MM CUP REAMER | HTO | REAMER | 1 | NA |
47 | 00817577022829 | 2100-1019 | 2100-1019 | 18MM CONE REAMER | HTO | REAMER | 1 | NA |
48 | 00817577022812 | 2100-1018 | 2100-1018 | 18MM CUP REAMER | HTO | REAMER | 1 | NA |
49 | 00817577022805 | 2100-1017 | 2100-1017 | 16MM CONE REAMER | HTO | REAMER | 1 | NA |
50 | 00817577022799 | 2100-1016 | 2100-1016 | 16MM CUP REAMER | HTO | REAMER | 1 | NA |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 08058964726087 | 900001 144818 | "Disposable cement spacer molds with metal reinforcement stem are indicated for "Disposable cement spacer molds with metal reinforcement stem are indicated for use to mold atemporary hemi- shoulder replacement for skeletally mature patients undergoing a two-stagerevision procedure due to a septic process.The temporary prosthesis is molded using low viscosity polymethylmethacrylate bonecement and inserted into the humeral medullary canal and glenoid cavity of the shoulderfollowing removal of the existing humeral and glenoideal cavity implants and debridement.SpaceFlex Shoulder should only be used with G3A low-viscosity bone cement.The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy(standard treatment approach to an infection).The hemi-shoulder prosthesis made from the SpaceFlex Shoulder disposable cement molds isnot intended for use more than 180 days, at which time it must be explanted and permanentdevices implanted or another appropriate treatment performed (e.g. resection arthroplasty,fusion, etc.).Due to the inherent mechanical limitations of the hemi-shoulder prosthesis material (lowviscosity polymethylmethacrylate), the temporary hemi-shoulder prosthesis is only indicatedfor patients who will consistently follow activity limitation throughout the implant period.The device can exclusively be used by competent healthcare personnel who has completescientific and anatomical knowledge." | SpaceFlex Shoulder | G21 SRL | |
2 | 08058964726070 | 900001 124818 | Disposable cement spacer molds with metal reinforcement stem are indicated for u Disposable cement spacer molds with metal reinforcement stem are indicated for use to mold atemporary hemi- shoulder replacement for skeletally mature patients undergoing a two-stagerevision procedure due to a septic process.The temporary prosthesis is molded using low viscosity polymethylmethacrylate bonecement and inserted into the humeral medullary canal and glenoid cavity of the shoulderfollowing removal of the existing humeral and glenoideal cavity implants and debridement.SpaceFlex Shoulder should only be used with G3A low-viscosity bone cement.The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy(standard treatment approach to an infection).The hemi-shoulder prosthesis made from the SpaceFlex Shoulder disposable cement molds isnot intended for use more than 180 days, at which time it must be explanted and permanentdevices implanted or another appropriate treatment performed (e.g. resection arthroplasty,fusion, etc.).Due to the inherent mechanical limitations of the hemi-shoulder prosthesis material (lowviscosity polymethylmethacrylate), the temporary hemi-shoulder prosthesis is only indicatedfor patients who will consistently follow activity limitation throughout the implant period.The device can exclusively be used by competent healthcare personnel who has completescientific and anatomical knowledge. | SpaceFlex Shoulder | G21 SRL | |
3 | 08058964726063 | 900001 124215 | Disposable cement spacer molds with metal reinforcement stem are indicated for u Disposable cement spacer molds with metal reinforcement stem are indicated for use to mold atemporary hemi- shoulder replacement for skeletally mature patients undergoing a two-stagerevision procedure due to a septic process.The temporary prosthesis is molded using low viscosity polymethylmethacrylate bonecement and inserted into the humeral medullary canal and glenoid cavity of the shoulderfollowing removal of the existing humeral and glenoideal cavity implants and debridement.SpaceFlex Shoulder should only be used with G3A low-viscosity bone cement.The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy(standard treatment approach to an infection).The hemi-shoulder prosthesis made from the SpaceFlex Shoulder disposable cement molds isnot intended for use more than 180 days, at which time it must be explanted and permanentdevices implanted or another appropriate treatment performed (e.g. resection arthroplasty,fusion, etc.).Due to the inherent mechanical limitations of the hemi-shoulder prosthesis material (lowviscosity polymethylmethacrylate), the temporary hemi-shoulder prosthesis is only indicatedfor patients who will consistently follow activity limitation throughout the implant period.The device can exclusively be used by competent healthcare personnel who has completescientific and anatomical knowledge. | SpaceFlex Shoulder | G21 SRL | |
4 | 08058964726056 | 900001 104818 | Disposable cement spacer molds with metal reinforcement stem are indicated for u Disposable cement spacer molds with metal reinforcement stem are indicated for use to mold atemporary hemi- shoulder replacement for skeletally mature patients undergoing a two-stagerevision procedure due to a septic process.The temporary prosthesis is molded using low viscosity polymethylmethacrylate bonecement and inserted into the humeral medullary canal and glenoid cavity of the shoulderfollowing removal of the existing humeral and glenoideal cavity implants and debridement.SpaceFlex Shoulder should only be used with G3A low-viscosity bone cement.The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy(standard treatment approach to an infection).The hemi-shoulder prosthesis made from the SpaceFlex Shoulder disposable cement molds isnot intended for use more than 180 days, at which time it must be explanted and permanentdevices implanted or another appropriate treatment performed (e.g. resection arthroplasty,fusion, etc.).Due to the inherent mechanical limitations of the hemi-shoulder prosthesis material (lowviscosity polymethylmethacrylate), the temporary hemi-shoulder prosthesis is only indicatedfor patients who will consistently follow activity limitation throughout the implant period.The device can exclusively be used by competent healthcare personnel who has completescientific and anatomical knowledge. | SpaceFlex Shoulder | G21 SRL | |
5 | 08058964726049 | 900001 104215 | Disposable cement spacer molds with metal reinforcement stem are indicated for u Disposable cement spacer molds with metal reinforcement stem are indicated for use to mold atemporary hemi- shoulder replacement for skeletally mature patients undergoing a two-stagerevision procedure due to a septic process.The temporary prosthesis is molded using low viscosity polymethylmethacrylate bonecement and inserted into the humeral medullary canal and glenoid cavity of the shoulderfollowing removal of the existing humeral and glenoideal cavity implants and debridement.SpaceFlex Shoulder should only be used with G3A low-viscosity bone cement.The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy(standard treatment approach to an infection).The hemi-shoulder prosthesis made from the SpaceFlex Shoulder disposable cement molds isnot intended for use more than 180 days, at which time it must be explanted and permanentdevices implanted or another appropriate treatment performed (e.g. resection arthroplasty,fusion, etc.).Due to the inherent mechanical limitations of the hemi-shoulder prosthesis material (lowviscosity polymethylmethacrylate), the temporary hemi-shoulder prosthesis is only indicatedfor patients who will consistently follow activity limitation throughout the implant period.The device can exclusively be used by competent healthcare personnel who has completescientific and anatomical knowledge. | SpaceFlex Shoulder | G21 SRL | |
6 | 08058964724977 | 900001 084215 | Disposable cement spacer molds with metal reinforcement stem are indicated for u Disposable cement spacer molds with metal reinforcement stem are indicated for use to mold atemporary hemi- shoulder replacement for skeletally mature patients undergoing a two-stagerevision procedure due to a septic process.The temporary prosthesis is molded using low viscosity polymethylmethacrylate bonecement and inserted into the humeral medullary canal and glenoid cavity of the shoulderfollowing removal of the existing humeral and glenoideal cavity implants and debridement.SpaceFlex Shoulder should only be used with G3A low-viscosity bone cement.The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy(standard treatment approach to an infection).The hemi-shoulder prosthesis made from the SpaceFlex Shoulder disposable cement molds isnot intended for use more than 180 days, at which time it must be explanted and permanentdevices implanted or another appropriate treatment performed (e.g. resection arthroplasty,fusion, etc.).Due to the inherent mechanical limitations of the hemi-shoulder prosthesis material (lowviscosity polymethylmethacrylate), the temporary hemi-shoulder prosthesis is only indicatedfor patients who will consistently follow activity limitation throughout the implant period.The device can exclusively be used by competent healthcare personnel who has completescientific and anatomical knowledge. | SpaceFlex Shoulder | G21 SRL | |
7 | 08033390244640 | 9CC0.13.03B | 9CC0.13.03B | Glenoid Drilling Guide Dia. 2,7 mm | ProMade | LIMACORPORATE SPA |
8 | 08033390244640 | 9CC0.13.03B | 9CC0.13.03B | Glenoid Drilling Guide Dia. 2,7 mm | ProMade | LIMACORPORATE SPA |
9 | 08033390237420 | 9CC0.13.03E | 9CC0.13.03E | M8 Long Handle | ProMade | LIMACORPORATE SPA |
10 | 08033390237420 | 9CC0.13.03E | 9CC0.13.03E | M8 Long Handle | ProMade | LIMACORPORATE SPA |
11 | 08033390237406 | 9CC0.13.03C | 9CC0.13.03C | M8 Handle with Flange | ProMade | LIMACORPORATE SPA |
12 | 08033390237406 | 9CC0.13.03C | 9CC0.13.03C | M8 Handle with Flange | ProMade | LIMACORPORATE SPA |
13 | 08033390237338 | 9CC0.13.038 | 9CC0.13.038 | Glenoid Drilling Guide - Dia. 3.2 mm Drill | ProMade | LIMACORPORATE SPA |
14 | 08033390237338 | 9CC0.13.038 | 9CC0.13.038 | Glenoid Drilling Guide - Dia. 3.2 mm Drill | ProMade | LIMACORPORATE SPA |
15 | 08033390216418 | 9013.67.146 | 9013.67.146 | PRIMA - Impactor Adaptor #6 | PRIMA | LIMACORPORATE SPA |
16 | 08033390230599 | 9CCS.10.001 | 9CCS.10.001 | ProMade shoulder 140° Reverse Resection Jig | SMR Shoulder | LIMACORPORATE SPA |
17 | 08033390230599 | 9CCS.10.001 | 9CCS.10.001 | ProMade shoulder 140° Reverse Resection Jig | SMR Shoulder | LIMACORPORATE SPA |
18 | 08033390230599 | 9CCS.10.001 | 9CCS.10.001 | ProMade shoulder 140° Reverse Resection Jig | SMR Shoulder | LIMACORPORATE SPA |
19 | 08033390226172 | 9CCS.13.003 | 9CCS.13.003 | Compactor S | SMR Shoulder | LIMACORPORATE SPA |
20 | 08033390226172 | 9CCS.13.003 | 9CCS.13.003 | Compactor S | SMR Shoulder | LIMACORPORATE SPA |
21 | 08033390226165 | 9CCS.13.002 | 9CCS.13.002 | Glenoid Drill Peg S | SMR Shoulder | LIMACORPORATE SPA |
22 | 08033390226165 | 9CCS.13.002 | 9CCS.13.002 | Glenoid Drill Peg S | SMR Shoulder | LIMACORPORATE SPA |
23 | 08033390216821 | 9013.67.067 | 9013.67.067 | PRIMA - Metaphyseal Size ring #7 | PRIMA | LIMACORPORATE SPA |
24 | 08033390216821 | 9013.67.067 | 9013.67.067 | PRIMA - Metaphyseal Size ring #7 | PRIMA | LIMACORPORATE SPA |
25 | 08033390216821 | 9013.67.067 | 9013.67.067 | PRIMA - Metaphyseal Size ring #7 | PRIMA | LIMACORPORATE SPA |
26 | 08033390216814 | 9013.67.066 | 9013.67.066 | PRIMA - Metaphyseal Size ring #6 | PRIMA | LIMACORPORATE SPA |
27 | 08033390216814 | 9013.67.066 | 9013.67.066 | PRIMA - Metaphyseal Size ring #6 | PRIMA | LIMACORPORATE SPA |
28 | 08033390216814 | 9013.67.066 | 9013.67.066 | PRIMA - Metaphyseal Size ring #6 | PRIMA | LIMACORPORATE SPA |
29 | 08033390216807 | 9013.67.064 | 9013.67.064 | PRIMA - Metaphyseal Size ring #4 | PRIMA | LIMACORPORATE SPA |
30 | 08033390216807 | 9013.67.064 | 9013.67.064 | PRIMA - Metaphyseal Size ring #4 | PRIMA | LIMACORPORATE SPA |
31 | 08033390216807 | 9013.67.064 | 9013.67.064 | PRIMA - Metaphyseal Size ring #4 | PRIMA | LIMACORPORATE SPA |
32 | 08033390216791 | 9013.67.065 | 9013.67.065 | PRIMA - Metaphyseal Size ring #5 | PRIMA | LIMACORPORATE SPA |
33 | 08033390216791 | 9013.67.065 | 9013.67.065 | PRIMA - Metaphyseal Size ring #5 | PRIMA | LIMACORPORATE SPA |
34 | 08033390216791 | 9013.67.065 | 9013.67.065 | PRIMA - Metaphyseal Size ring #5 | PRIMA | LIMACORPORATE SPA |
35 | 08033390216784 | 9013.67.063 | 9013.67.063 | PRIMA - Metaphyseal Size ring #3 | PRIMA | LIMACORPORATE SPA |
36 | 08033390216784 | 9013.67.063 | 9013.67.063 | PRIMA - Metaphyseal Size ring #3 | PRIMA | LIMACORPORATE SPA |
37 | 08033390216784 | 9013.67.063 | 9013.67.063 | PRIMA - Metaphyseal Size ring #3 | PRIMA | LIMACORPORATE SPA |
38 | 08033390216777 | 9013.67.062 | 9013.67.062 | PRIMA - Metaphyseal Size ring #2 | PRIMA | LIMACORPORATE SPA |
39 | 08033390216777 | 9013.67.062 | 9013.67.062 | PRIMA - Metaphyseal Size ring #2 | PRIMA | LIMACORPORATE SPA |
40 | 08033390216777 | 9013.67.062 | 9013.67.062 | PRIMA - Metaphyseal Size ring #2 | PRIMA | LIMACORPORATE SPA |
41 | 08033390216760 | 9013.67.061 | 9013.67.061 | PRIMA - Metaphyseal Size ring #1 | PRIMA | LIMACORPORATE SPA |
42 | 08033390216760 | 9013.67.061 | 9013.67.061 | PRIMA - Metaphyseal Size ring #1 | PRIMA | LIMACORPORATE SPA |
43 | 08033390216760 | 9013.67.061 | 9013.67.061 | PRIMA - Metaphyseal Size ring #1 | PRIMA | LIMACORPORATE SPA |
44 | 08033390216609 | 9013.67.140 | 9013.67.140 | PRIMA - Impactor | PRIMA | LIMACORPORATE SPA |
45 | 08033390216609 | 9013.67.140 | 9013.67.140 | PRIMA - Impactor | PRIMA | LIMACORPORATE SPA |
46 | 08033390216609 | 9013.67.140 | 9013.67.140 | PRIMA - Impactor | PRIMA | LIMACORPORATE SPA |
47 | 08033390216470 | 9013.67.141 | 9013.67.141 | PRIMA - Impactor Adaptor #1 | PRIMA | LIMACORPORATE SPA |
48 | 08033390216470 | 9013.67.141 | 9013.67.141 | PRIMA - Impactor Adaptor #1 | PRIMA | LIMACORPORATE SPA |
49 | 08033390216470 | 9013.67.141 | 9013.67.141 | PRIMA - Impactor Adaptor #1 | PRIMA | LIMACORPORATE SPA |
50 | 08033390216463 | 9013.67.055 | 9013.67.055 | PRIMA - Metaphyseal Centering Guide - LEFT | PRIMA | LIMACORPORATE SPA |