No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00845694041133 | 395-4001-30 | 395-4001-30 | Tag, 0 Degree ExtremiFuse, 3.0 | HWC | Screw, fixation, bone | 2 | OsteoMed |
2 | 00845694041126 | 395-4001-24 | 395-4001-24 | Tag, 0 Degree ExtremiFuse, 2.4 | HWC | Screw, fixation, bone | 2 | OsteoMed |
3 | 00845694041119 | 395-4001-00 | 395-4001-00 | Tag, 0 Degree ExtremiFuse, Blank | HWC | Screw, fixation, bone | 2 | OsteoMed |
4 | 00845694041102 | 395-4000 | 395-4000 | ExtremiFuse Organizer Block | HWC | Screw, fixation, bone | 2 | OsteoMed |
5 | 00845694041096 | 395-2430 | 395-2430 | X-Ray Template, ExtremiFuse | HWC | Screw, fixation, bone | 2 | OsteoMed |
6 | 00845694041089 | 395-2200 | 395-2200 | ExtremiFuse Dual Cannulated Driver Handle | HWC | Screw, fixation, bone | 2 | OsteoMed |
7 | 00845694041072 | 395-2124 | 395-2124 | Broach, ExtremiFuse | HWC | Screw, fixation, bone | 2 | OsteoMed |
8 | 00845694041065 | 395-2027 | 395-2027 | Ø2.7mm Cannulated Drill, Quick Release | HWC | Screw, fixation, bone | 2 | OsteoMed |
9 | 00845694041058 | 395-2000 | 395-2000 | .035 x 3 K-Wire | HWC | Screw, fixation, bone | 2 | OsteoMed |
10 | 00845694041041 | 386-1705 | 386-1705 | Extraction System Tray | KWD | PROSTHESIS, TOE, HEMI-, PHALANGEAL | 2 | OsteoMed |
11 | 00845694041034 | 320-1029 | 320-1029 | Plate Bending Forceps, Large | HRS | Plate, fixation, bone | 2 | OsteoMed |
12 | 00845694041027 | 319-1030 | 319-1030 | 3.0mm x 10 Degree ExtremiFuse Implant | HWC | Screw, fixation, bone | 2 | OsteoMed |
13 | 00845694041010 | 319-1024 | 319-1024 | 2.4mm x 10 Degree ExtremiFuse Implant | HWC | Screw, fixation, bone | 2 | OsteoMed |
14 | 00845694041003 | 319-0030 | 319-0030 | 3.0mm x 0 Degree ExtremiFuse Implant | HWC | Screw, fixation, bone | 2 | OsteoMed |
15 | 00845694040990 | 319-0024 | 319-0024 | 2.4mm x 0 Degree ExtremiFuse Implant | HWC | Screw, fixation, bone | 2 | OsteoMed |
16 | 00845694040969 | 213-0127 | 213-0127 | 1.6mm, Left Zed Plate, 11mm | DZL | SCREW, FIXATION, INTRAOSSEOUS | 2 | OsteoMed |
17 | 00845694040952 | 213-0126 | 213-0126 | 1.6mm, Right Zed Plate, 11mm | DZL | SCREW, FIXATION, INTRAOSSEOUS | 2 | OsteoMed |
18 | 00845694040945 | 210-0255 | 210-0255 | 2.0mm Left L Plate, 23mm, Rigid | DZL | SCREW, FIXATION, INTRAOSSEOUS | 2 | OsteoMed |
19 | 00845694040938 | 210-0254 | 210-0254 | 2.0mm Right L Plate, 23mm, Rigid | DZL | SCREW, FIXATION, INTRAOSSEOUS | 2 | OsteoMed |
20 | 00845694040921 | 210-0253 | 210-0253 | 2.0mm Left L Plate, 18mm, Rigid | DZL | SCREW, FIXATION, INTRAOSSEOUS | 2 | OsteoMed |
21 | 00845694040914 | 210-0252 | 210-0252 | 2.0mm Right L Plate, 18mm, Rigid | DZL | SCREW, FIXATION, INTRAOSSEOUS | 2 | OsteoMed |
22 | 00845694040907 | 210-0251 | 210-0251 | 2.0mm Left L Plate, 15mm, Rigid | DZL | SCREW, FIXATION, INTRAOSSEOUS | 2 | OsteoMed |
23 | 00845694040891 | 210-0250 | 210-0250 | 2.0mm Right L Plate, 15mm, Rigid | DZL | SCREW, FIXATION, INTRAOSSEOUS | 2 | OsteoMed |
24 | 00845694040884 | 211-1606-REV-G | 211-1606-REV-G | 1.6mm x 6mm AUTO-DRIVE Screw | HWC | Screw, fixation, bone | 2 | OsteoMed |
25 | 00845694040877 | 213-0018-SP | 213-0018-SP | 1.6mm Rigid Curved Plate, 10 Hole, Sterile | DZL | SCREW, FIXATION, INTRAOSSEOUS | 2 | OsteoMed |
26 | 00845694040860 | 212-0052-SP | 212-0052-SP | 19mm T Plate, Sterile | JEY | PLATE, BONE | 2 | OsteoMed |
27 | 00845694040853 | 212-0046-SP | 212-0046-SP | 13mm Right L Plate, Sterile | JEY | PLATE, BONE | 2 | OsteoMed |
28 | 00845694040846 | 212-0044-SP | 212-0044-SP | 13mm Left L Plate, Sterile | JEY | PLATE, BONE | 2 | OsteoMed |
29 | 00845694040839 | 212-0030-SP | 212-0030-SP | 7 Hole Y Plate, Sterile | DZL | SCREW, FIXATION, INTRAOSSEOUS | 2 | OsteoMed |
30 | 00845694040822 | 213-0011-SP | 213-0011-SP | 10 Hole Curved Plate, Sterile | DZL | SCREW, FIXATION, INTRAOSSEOUS | 2 | OsteoMed |
31 | 00845694040815 | 817-1017 | 817-1017 | PrimaLIF LLIF 17mm x 26mm Lordotic Trial | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | OsteoMed |
32 | 00845694040808 | 817-1015 | 817-1015 | PrimaLIF LLIF 15mm x 26mm Lordotic Trial | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | OsteoMed |
33 | 00845694040792 | 817-1013 | 817-1013 | PrimaLIF LLIF 13mm x 26mm Lordotic Trial | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | OsteoMed |
34 | 00845694040785 | 817-1011 | 817-1011 | PrimaLIF LLIF 11mm x 26mm Lordotic Trial | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | OsteoMed |
35 | 00845694040778 | 817-1009 | 817-1009 | PrimaLIF LLIF 9mm x 26mm Lordotic Trial | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | OsteoMed |
36 | 00845694040761 | 817-1007 | 817-1007 | PrimaLIF LLIF 7mm x 26mm Lordotic Trial | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | OsteoMed |
37 | 00845694040754 | 816-1017 | 816-1017 | PrimaLIF LLIF 17mm x 22mm Lordotic Trial | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | OsteoMed |
38 | 00845694040747 | 816-1015 | 816-1015 | PrimaLIF LLIF 15mm x 22mm Lordotic Trial | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | OsteoMed |
39 | 00845694040730 | 816-1013 | 816-1013 | PrimaLIF LLIF 13mm x 22mm Lordotic Trial | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | OsteoMed |
40 | 00845694040723 | 816-1011 | 816-1011 | PrimaLIF LLIF 11mm x 22mm Lordotic Trial | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | OsteoMed |
41 | 00845694040716 | 816-1009 | 816-1009 | PrimaLIF LLIF 9mm x 22mm Lordotic Trial | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | OsteoMed |
42 | 00845694040709 | 816-1007 | 816-1007 | PrimaLIF LLIF 7mm x 22mm Lordotic Trial | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | OsteoMed |
43 | 00845694040693 | 815-1017 | 815-1017 | PrimaLIF LLIF 17mm x 18mm Lordotic Trial | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | OsteoMed |
44 | 00845694040686 | 815-1015 | 815-1015 | PrimaLIF LLIF 15mm x 18mm Lordotic Trial | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | OsteoMed |
45 | 00845694040679 | 815-1013 | 815-1013 | PrimaLIF LLIF 13mm x 18mm Lordotic Trial | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | OsteoMed |
46 | 00845694040662 | 815-1011 | 815-1011 | PrimaLIF LLIF 11mm x 18mm Lordotic Trial | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | OsteoMed |
47 | 00845694040655 | 815-1009 | 815-1009 | PrimaLIF LLIF 9mm x 18mm Lordotic Trial | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | OsteoMed |
48 | 00845694040648 | 815-1007 | 815-1007 | PrimaLIF LLIF 7mm x 18mm Lordotic Trial | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | OsteoMed |
49 | 00845694040631 | 814-1017 | 814-1017 | PrimaLIF LLIF 17mm x 26mm Parallel Trial | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | OsteoMed |
50 | 00845694040624 | 814-1015 | 814-1015 | PrimaLIF LLIF 15mm x 26mm Parallel Trial | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | OsteoMed |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 08057432565746 | ACP-04T526 | ACP | SINTEA PLUSTEK SRL | ||
2 | 08057432565739 | ACP-04T525 | ACP | SINTEA PLUSTEK SRL | ||
3 | 08057432565678 | PLS-49T5300 | PLS | SINTEA PLUSTEK SRL | ||
4 | 08057432565661 | PLS-49T5200 | PLS | SINTEA PLUSTEK SRL | ||
5 | 08057432565654 | PLS-49T5140 | PLS | SINTEA PLUSTEK SRL | ||
6 | 08057432565647 | PLS-49T5130 | PLS | SINTEA PLUSTEK SRL | ||
7 | 08057432565630 | PLS-48T5140 | PLS | SINTEA PLUSTEK SRL | ||
8 | 08057432565623 | PLS-48T5130 | PLS | SINTEA PLUSTEK SRL | ||
9 | 08057432565616 | PLS-48T5090 | PLS | SINTEA PLUSTEK SRL | ||
10 | 08057432565609 | PLS-48T5085 | PLS | SINTEA PLUSTEK SRL | ||
11 | 08057432565593 | PLS-48T5080 | PLS | SINTEA PLUSTEK SRL | ||
12 | 08057432565586 | PLS-48T5075 | PLS | SINTEA PLUSTEK SRL | ||
13 | 08057432565579 | PLS-48T5070 | PLS | SINTEA PLUSTEK SRL | ||
14 | 08057432565562 | PLS-48T5065 | PLS | SINTEA PLUSTEK SRL | ||
15 | 08057432565555 | PLS-48T5060 | PLS | SINTEA PLUSTEK SRL | ||
16 | 08057432565548 | PLS-48T5055 | PLS | SINTEA PLUSTEK SRL | ||
17 | 08057432565531 | PLS-48T5050 | PLS | SINTEA PLUSTEK SRL | ||
18 | 08057432565524 | PLS-48T5045 | PLS | SINTEA PLUSTEK SRL | ||
19 | 08057432565517 | PLS-48T5040 | PLS | SINTEA PLUSTEK SRL | ||
20 | 08057432565500 | PLS-48T5035 | PLS | SINTEA PLUSTEK SRL | ||
21 | 08057432565494 | PLS-48T5030 | PLS | SINTEA PLUSTEK SRL | ||
22 | 08057432565487 | PLS-48CC8 | PLS | SINTEA PLUSTEK SRL | ||
23 | 08057432565470 | PLS-48CC6 | PLS | SINTEA PLUSTEK SRL | ||
24 | 08057432565463 | PLS-48CC5 | PLS | SINTEA PLUSTEK SRL | ||
25 | 08057432565456 | PLS-48CC4 | PLS | SINTEA PLUSTEK SRL | ||
26 | 08057432565449 | PLS-48CC3 | PLS | SINTEA PLUSTEK SRL | ||
27 | 08057432565432 | PLS-48CC2 | PLS | SINTEA PLUSTEK SRL | ||
28 | 08057432565425 | PLS-48CC1 | PLS | SINTEA PLUSTEK SRL | ||
29 | 08057432565418 | PLS-47CC4 | PLS | SINTEA PLUSTEK SRL | ||
30 | 08057432565401 | PLS-47CC3 | PLS | SINTEA PLUSTEK SRL | ||
31 | 08057432565395 | PLS-47CC2 | PLS | SINTEA PLUSTEK SRL | ||
32 | 08057432565388 | PLS-760T58 | https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI& https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548# | PLS | SINTEA PLUSTEK SRL | |
33 | 08057432565371 | PLS-760T57 | https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI& https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548# | PLS | SINTEA PLUSTEK SRL | |
34 | 08057432565364 | PLS-760T56 | PLS | SINTEA PLUSTEK SRL | ||
35 | 08057432565357 | PLS-760T55 | https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI& https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548# | PLS | SINTEA PLUSTEK SRL | |
36 | 08057432565340 | PLS-760T540 | https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI& https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548# | PLS | SINTEA PLUSTEK SRL | |
37 | 08057432565333 | PLS-755T540 | https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI& https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548# | PLS | SINTEA PLUSTEK SRL | |
38 | 08057432565326 | PLS-660T58 | https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI& https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548# | PLS | SINTEA PLUSTEK SRL | |
39 | 08057432565319 | PLS-655T58 | https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI& https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548# | PLS | SINTEA PLUSTEK SRL | |
40 | 08057432565302 | PLS-650T58 | https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI& https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548# | PLS | SINTEA PLUSTEK SRL | |
41 | 08057432565296 | PLS-645T58 | https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI& https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548# | PLS | SINTEA PLUSTEK SRL | |
42 | 08057432565289 | PLS-640T58 | https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI& https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548# | PLS | SINTEA PLUSTEK SRL | |
43 | 08057432565272 | PLS-635T58 | https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI& https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548# | PLS | SINTEA PLUSTEK SRL | |
44 | 08057432565265 | PLS-630T58 | https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI& https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548# | PLS | SINTEA PLUSTEK SRL | |
45 | 08057432565258 | PLS-6100T58 | https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI& https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548# | PLS | SINTEA PLUSTEK SRL | |
46 | 08057432565241 | PLS-6095T58 | https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI& https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548# | PLS | SINTEA PLUSTEK SRL | |
47 | 08057432565234 | PLS-6090T58 | https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI& https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548# | PLS | SINTEA PLUSTEK SRL | |
48 | 08057432565227 | PLS-6085T58 | https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI& https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548# | PLS | SINTEA PLUSTEK SRL | |
49 | 08057432565210 | PLS-6080T58 | https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI& https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548# | PLS | SINTEA PLUSTEK SRL | |
50 | 08057432565203 | PLS-6075T58 | https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI& https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=419548# | PLS | SINTEA PLUSTEK SRL |