No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | M711CRT006ST0 | CRT006ST | CP Ti | GWO | Plate, Cranioplasty, Preformed, Alterable | 2 | Neuro & Craniofacial Fixation System | |
2 | M711BTA1190 | BTA-119 | Al, SST, Nylon, Silicone | LXH | Orthopedic Manual Surgical Instrument | 1 | PSO | |
3 | M711X212163200 | X21216320 | X21216320 | PEEK, Ta | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Px™ |
4 | M711X212163000 | X21216300 | X21216300 | PEEK, Ta | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Px™ |
5 | M711X212162800 | X21216280 | X21216280 | PEEK, Ta | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Px™ |
6 | M711X212153200 | X21215320 | X21215320 | PEEK, Ta | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Px™ |
7 | M711X212153000 | X21215300 | X21215300 | PEEK, Ta | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Px™ |
8 | M711X212152800 | X21215280 | X21215280 | PEEK, Ta | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Px™ |
9 | M711X212143200 | X21214320 | X21214320 | PEEK, Ta | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Px™ |
10 | M711X212143000 | X21214300 | X21214300 | PEEK, Ta | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Px™ |
11 | M711X212142800 | X21214280 | X21214280 | PEEK, Ta | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Px™ |
12 | M711X212133200 | X21213320 | X21213320 | PEEK, Ta | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Px™ |
13 | M711X212133000 | X21213300 | X21213300 | PEEK, Ta | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Px™ |
14 | M711X212132800 | X21213280 | X21213280 | PEEK, Ta | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Px™ |
15 | M711X212123200 | X21212320 | X21212320 | PEEK, Ta | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Px™ |
16 | M711X212123000 | X21212300 | X21212300 | PEEK, Ta | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Px™ |
17 | M711X212122800 | X21212280 | X21212280 | PEEK, Ta | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Px™ |
18 | M711X212113200 | X21211320 | X21211320 | PEEK, Ta | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Px™ |
19 | M711X212113000 | X21211300 | X21211300 | PEEK, Ta | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Px™ |
20 | M711X212112800 | X21211280 | X21211280 | PEEK, Ta | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Px™ |
21 | M711X212103200 | X21210320 | X21210320 | PEEK, Ta | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Px™ |
22 | M711X212103000 | X21210300 | X21210300 | PEEK, Ta | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Px™ |
23 | M711X212102800 | X21210280 | X21210280 | PEEK, Ta | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Px™ |
24 | M711X212093200 | X21209320 | X21209320 | PEEK, Ta | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Px™ |
25 | M711X212093000 | X21209300 | X21209300 | PEEK, Ta | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Px™ |
26 | M711X212092800 | X21209280 | X21209280 | PEEK, Ta | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Px™ |
27 | M711X212082800 | X21208280 | X21208280 | PEEK, Ta | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Px™ |
28 | M711X210162550 | X21016255 | X21016255 | PEEK, Ta | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Px™ |
29 | M711X210162500 | X21016250 | X21016250 | PEEK, Ta | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Px™ |
30 | M711X210162250 | X21016225 | X21016225 | PEEK, Ta | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Px™ |
31 | M711X210162200 | X21016220 | X21016220 | PEEK, Ta | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Px™ |
32 | M711X210153200 | X21015320 | X21015320 | PEEK, Ta | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Px™ |
33 | M711X210152800 | X21015280 | X21015280 | PEEK, Ta | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Px™ |
34 | M711X210152550 | X21015255 | X21015255 | PEEK, Ta | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Px™ |
35 | M711X210152500 | X21015250 | X21015250 | PEEK, Ta | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Px™ |
36 | M711X210152250 | X21015225 | X21015225 | PEEK, Ta | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Px™ |
37 | M711X210152200 | X21015220 | X21015220 | PEEK, Ta | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Px™ |
38 | M711X210143200 | X21014320 | X21014320 | PEEK, Ta | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Px™ |
39 | M711X210142800 | X21014280 | X21014280 | PEEK, Ta | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Px™ |
40 | M711X210142550 | X21014255 | X21014255 | PEEK, Ta | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Px™ |
41 | M711X210142500 | X21014250 | X21014250 | PEEK, Ta | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Px™ |
42 | M711X210142250 | X21014225 | X21014225 | PEEK, Ta | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Px™ |
43 | M711X210142200 | X21014220 | X21014220 | PEEK, Ta | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Px™ |
44 | M711X210133200 | X21013320 | X21013320 | PEEK, Ta | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Px™ |
45 | M711X210132800 | X21013280 | X21013280 | PEEK, Ta | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Px™ |
46 | M711X210132550 | X21013255 | X21013255 | PEEK, Ta | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Px™ |
47 | M711X210132500 | X21013250 | X21013250 | PEEK, Ta | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Px™ |
48 | M711X210132250 | X21013225 | X21013225 | PEEK, Ta | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Px™ |
49 | M711X210132200 | X21013220 | X21013220 | PEEK, Ta | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Px™ |
50 | M711X210123200 | X21012320 | X21012320 | PEEK, Ta | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Px™ |
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 |