No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00815101021294 | M301720c | OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 2 | MIDLINE II-Ti | ||
2 | 00815101027210 | PCT0435065 | NKG,KWP | Orthosis, Cervical Pedicle Screw Spinal Fixation,Appliance, Fixation, Spinal Interlaminal | 2 | PCT | ||
3 | 00815101027203 | PCT0435060 | KWP,NKG | Appliance, Fixation, Spinal Interlaminal,Orthosis, Cervical Pedicle Screw Spinal Fixation | 2 | PCT | ||
4 | 00815101027180 | PCT0435050 | KWP,NKG | Appliance, Fixation, Spinal Interlaminal,Orthosis, Cervical Pedicle Screw Spinal Fixation | 2 | PCT | ||
5 | 00815101027142 | PCT0435030 | KWP,NKG | Appliance, Fixation, Spinal Interlaminal,Orthosis, Cervical Pedicle Screw Spinal Fixation | 2 | PCT | ||
6 | 00815101027036 | PCT0340195 | NKG,KWP | Orthosis, Cervical Pedicle Screw Spinal Fixation,Appliance, Fixation, Spinal Interlaminal | 2 | PCT | ||
7 | 00815101027005 | PCT0340185 | NKG,KWP | Orthosis, Cervical Pedicle Screw Spinal Fixation,Appliance, Fixation, Spinal Interlaminal | 2 | PCT | ||
8 | 00815101026817 | PCT0340090 | KWP,NKG | Appliance, Fixation, Spinal Interlaminal,Orthosis, Cervical Pedicle Screw Spinal Fixation | 2 | PCT | ||
9 | 00815101026701 | PCT0340035 | KWP,NKG | Appliance, Fixation, Spinal Interlaminal,Orthosis, Cervical Pedicle Screw Spinal Fixation | 2 | PCT | ||
10 | 00815101026619 | PCT0335205 | NKG,KWP | Orthosis, Cervical Pedicle Screw Spinal Fixation,Appliance, Fixation, Spinal Interlaminal | 2 | PCT | ||
11 | 00815101026602 | PCT0335200 | KWP,NKG | Appliance, Fixation, Spinal Interlaminal,Orthosis, Cervical Pedicle Screw Spinal Fixation | 2 | PCT | ||
12 | 00815101026572 | PCT0335185 | KWP,NKG | Appliance, Fixation, Spinal Interlaminal,Orthosis, Cervical Pedicle Screw Spinal Fixation | 2 | PCT | ||
13 | 00815101026565 | PCT0335180 | NKG,KWP | Orthosis, Cervical Pedicle Screw Spinal Fixation,Appliance, Fixation, Spinal Interlaminal | 2 | PCT | ||
14 | 00815101026558 | PCT0335175 | KWP,NKG | Appliance, Fixation, Spinal Interlaminal,Orthosis, Cervical Pedicle Screw Spinal Fixation | 2 | PCT | ||
15 | 00815101026442 | PCT0335120 | NKG,KWP | Orthosis, Cervical Pedicle Screw Spinal Fixation,Appliance, Fixation, Spinal Interlaminal | 2 | PCT | ||
16 | 00815101026404 | PCT0335100 | NKG,KWP | Orthosis, Cervical Pedicle Screw Spinal Fixation,Appliance, Fixation, Spinal Interlaminal | 2 | PCT | ||
17 | 00815101026374 | PCT0335085 | KWP,NKG | Appliance, Fixation, Spinal Interlaminal,Orthosis, Cervical Pedicle Screw Spinal Fixation | 2 | PCT | ||
18 | 00815101026367 | PCT0335080 | NKG,KWP | Orthosis, Cervical Pedicle Screw Spinal Fixation,Appliance, Fixation, Spinal Interlaminal | 2 | PCT | ||
19 | 00815101026350 | PCT0335075 | KWP,NKG | Appliance, Fixation, Spinal Interlaminal,Orthosis, Cervical Pedicle Screw Spinal Fixation | 2 | PCT | ||
20 | 00815101026343 | PCT0335070 | NKG,KWP | Orthosis, Cervical Pedicle Screw Spinal Fixation,Appliance, Fixation, Spinal Interlaminal | 2 | PCT | ||
21 | 00815101026336 | PCT0335065 | KWP,NKG | Appliance, Fixation, Spinal Interlaminal,Orthosis, Cervical Pedicle Screw Spinal Fixation | 2 | PCT | ||
22 | 00815101026299 | PCT0335045 | KWP,NKG | Appliance, Fixation, Spinal Interlaminal,Orthosis, Cervical Pedicle Screw Spinal Fixation | 2 | PCT | ||
23 | 00815101026244 | PCT06WR006 | KWP,NKG | Appliance, Fixation, Spinal Interlaminal,Orthosis, Cervical Pedicle Screw Spinal Fixation | 2 | PCT | ||
24 | 00815101026176 | PCT06OR005 | NKG,KWP | Orthosis, Cervical Pedicle Screw Spinal Fixation,Appliance, Fixation, Spinal Interlaminal | 2 | PCT | ||
25 | 00815101026169 | PCT06OR004 | KWP,NKG | Appliance, Fixation, Spinal Interlaminal,Orthosis, Cervical Pedicle Screw Spinal Fixation | 2 | PCT | ||
26 | 00815101026107 | PCT0245050 | NKG,KWP | Orthosis, Cervical Pedicle Screw Spinal Fixation,Appliance, Fixation, Spinal Interlaminal | 2 | PCT | ||
27 | 00815101026091 | PCT0245049 | KWP,NKG | Appliance, Fixation, Spinal Interlaminal,Orthosis, Cervical Pedicle Screw Spinal Fixation | 2 | PCT | ||
28 | 00815101026077 | PCT0245047 | KWP,NKG | Appliance, Fixation, Spinal Interlaminal,Orthosis, Cervical Pedicle Screw Spinal Fixation | 2 | PCT | ||
29 | 00815101026060 | PCT0245046 | NKG,KWP | Orthosis, Cervical Pedicle Screw Spinal Fixation,Appliance, Fixation, Spinal Interlaminal | 2 | PCT | ||
30 | 00815101026039 | PCT0245043 | KWP,NKG | Appliance, Fixation, Spinal Interlaminal,Orthosis, Cervical Pedicle Screw Spinal Fixation | 2 | PCT | ||
31 | 00815101026015 | PCT0245041 | KWP,NKG | Appliance, Fixation, Spinal Interlaminal,Orthosis, Cervical Pedicle Screw Spinal Fixation | 2 | PCT | ||
32 | 00815101025988 | PCT0245038 | NKG,KWP | Orthosis, Cervical Pedicle Screw Spinal Fixation,Appliance, Fixation, Spinal Interlaminal | 2 | PCT | ||
33 | 00815101025964 | PCT0245036 | NKG,KWP | Orthosis, Cervical Pedicle Screw Spinal Fixation,Appliance, Fixation, Spinal Interlaminal | 2 | PCT | ||
34 | 00815101025902 | PCT0245030 | NKG,KWP | Orthosis, Cervical Pedicle Screw Spinal Fixation,Appliance, Fixation, Spinal Interlaminal | 2 | PCT | ||
35 | 00815101025872 | PCT0245027 | KWP,NKG | Appliance, Fixation, Spinal Interlaminal,Orthosis, Cervical Pedicle Screw Spinal Fixation | 2 | PCT | ||
36 | 00815101025858 | PCT0245025 | KWP,NKG | Appliance, Fixation, Spinal Interlaminal,Orthosis, Cervical Pedicle Screw Spinal Fixation | 2 | PCT | ||
37 | 00815101025803 | PCT0245020 | NKG,KWP | Orthosis, Cervical Pedicle Screw Spinal Fixation,Appliance, Fixation, Spinal Interlaminal | 2 | PCT | ||
38 | 00815101025780 | PCT0240049 | NKG,KWP | Orthosis, Cervical Pedicle Screw Spinal Fixation,Appliance, Fixation, Spinal Interlaminal | 2 | PCT | ||
39 | 00815101025605 | PCT0240031 | NKG,KWP | Orthosis, Cervical Pedicle Screw Spinal Fixation,Appliance, Fixation, Spinal Interlaminal | 2 | PCT | ||
40 | 00815101025599 | PCT0240030 | KWP,NKG | Appliance, Fixation, Spinal Interlaminal,Orthosis, Cervical Pedicle Screw Spinal Fixation | 2 | PCT | ||
41 | 00815101025551 | PCT0240026 | KWP,NKG | Appliance, Fixation, Spinal Interlaminal,Orthosis, Cervical Pedicle Screw Spinal Fixation | 2 | PCT | ||
42 | 00815101025391 | PCT0235040 | KWP,NKG | Appliance, Fixation, Spinal Interlaminal,Orthosis, Cervical Pedicle Screw Spinal Fixation | 2 | PCT | ||
43 | 00815101025278 | PCT0235028 | KWP,NKG | Appliance, Fixation, Spinal Interlaminal,Orthosis, Cervical Pedicle Screw Spinal Fixation | 2 | PCT | ||
44 | 00815101025209 | PCT0235021 | NKG,KWP | Orthosis, Cervical Pedicle Screw Spinal Fixation,Appliance, Fixation, Spinal Interlaminal | 2 | PCT | ||
45 | 00815101025674 | PCT0240038 | KWP,NKG | Appliance, Fixation, Spinal Interlaminal,Orthosis, Cervical Pedicle Screw Spinal Fixation | 2 | PCT | ||
46 | 00815101021584 | M361516c | OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 2 | MIDLINE II-Ti | ||
47 | 00815101021300 | M301920c | OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 2 | MIDLINE II-Ti | ||
48 | 00815101020136 | M302112 | OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 2 | MIDLINE II | ||
49 | 00815101020051 | M301708 | OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 2 | MIDLINE II | ||
50 | 00815101024790 | PCT0145010 | KWP,NKG | Appliance, Fixation, Spinal Interlaminal,Orthosis, Cervical Pedicle Screw Spinal Fixation | 2 | PCT |
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 |