No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00885074459639 | 8361234 | SCREW REMOVAL | FSM | TRAY, SURGICAL, INSTRUMENT | 1 | n/a | |
2 | 00885074378404 | 9960136 | DISTRACTOR 9960136 TLIF | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | N/A | |
3 | 00885074351087 | 1701188R | TSRH-3D IMPLANT TRAY | FSM | TRAY, SURGICAL, INSTRUMENT | 1 | N/A | |
4 | 00885074154527 | 8670016 | PAK KIT LOANER TRAY | FSM | TRAY, SURGICAL, INSTRUMENT | 1 | N/A | |
5 | 00885074087801 | 2940352 | INSTRUMENT 2940352 11MM SHAVER | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | N/A | |
6 | 00885074034089 | 7480885 | INSTRUMENT 7480885 8.5MM TAP | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | N/A | |
7 | 00763000361204 | EX0220004 | HOLDER EX0220004 BLADE | GAD | RETRACTOR | 1 | n/a | |
8 | 00763000205256 | 9010009001 | DRIVER 9010009001 T27 SET SCREW DRIVER | HXX | SCREWDRIVER | 1 | n/a | |
9 | 00763000191818 | X0518057 | INSERTER X0518057 SOVEREIGN RED PROFILE | MAX,OVD | Intervertebral fusion device with bone graft, lumbar,Intervertebral fusion devic Intervertebral fusion device with bone graft, lumbar,Intervertebral fusion device with integrated fixation, lumbar | 2 | N/A | |
10 | 00763000140021 | 9564030 | DILATOR 9564030 MICRO | GAD | RETRACTOR | 1 | NA | |
11 | 00721902974793 | 6971114 | INSTRUMENT 6971114 MALLET | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | N/A | |
12 | 00763000036331 | 9450051 | DISPOSABLE 9450051 NIM 2.3MM BLL TIP PRB | ETN | STIMULATOR, NERVE | 2 | N/A | |
13 | 00721902983849 | 9198903 | CASE 9198903 INS LOWER TRAY 1 | FSM | TRAY, SURGICAL, INSTRUMENT | 1 | n/a | |
14 | 00721902725913 | X8683509 | INSTRUMENT X8683509 THOR TAP 3 5MM | HWX | TAP, BONE | 1 | N/A | |
15 | 00721902689611 | 185-460L | LID 185-460L GENERIC 1/2 TRAY | FSM | TRAY, SURGICAL, INSTRUMENT | 1 | N/A | |
16 | 00721902648236 | 8161020 | INSTRUMENT 8161020 S 2PRNG STPL HLDR | MNI,KWQ,KWP,MNH | ORTHOSIS, SPINAL PEDICLE FIXATION,APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BOD ORTHOSIS, SPINAL PEDICLE FIXATION,APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY,APPLIANCE, FIXATION, SPINAL INTERLAMINAL,Orthosis, spondylolisthesis spinal fixation | 2 | N/A | |
17 | 00681490902939 | 8691016 | INSTRUMENT 8691016 CRSLK MSR TL CRD 19MM | HWT | TEMPLATE | 1 | N/A | |
18 | 00681490002387 | Y895-I16FO | REAMER | HTO | REAMER | 1 | Medtronic Reusable Instruments | |
19 | 00673978141268 | X0598-006 | WIRE X0598-006 30 NON-THREAD UCSS WIRE | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | N/A | |
20 | 00673978072395 | 890-501 | INSTRUMENT 890-501 REMOVER LARGE | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | N/A | |
21 | 00673978070841 | 876-468 | INSTRUMENT 876-468 DEPTH GAUGE | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | N/A | |
22 | 00673978069050 | 875-078 | INSTRUMENT 875-078 14MM DISTRACTOR PINS | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | N/A | |
23 | 00673978050515 | 836-018 | INSTRUMENT 836-018 SOLID TAP 7.5MM | HWX | TAP, BONE | 1 | N/A | |
24 | 00673978011394 | 185-064 | CASE 185-064 CD HORIZON BASELID STEAM | FSM | TRAY, SURGICAL, INSTRUMENT | 1 | N/A | |
25 | 00643169997134 | EX0317034 | RASP EX0317034 15DEG | HTR | RASP | 1 | n/a | |
26 | 00643169791473 | EX0316012 | RETRACTOR EX0316012 TRIMLINE | GAD | RETRACTOR | 1 | N/A | |
27 | 00643169766815 | EX0416033 | PIN EX0416033 PLATE HOLDING | FZX | Guide, surgical, instrument | 1 | N/A | |
28 | 00643169762022 | EX0416028 | INSERTER EX0416028 STRAIGHT BONE | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | N/A | |
29 | 00643169672840 | NAV2080K | TAP NAV2080K VERT TAP 4.5MM | OLO | Orthopedic stereotaxic instrument | 2 | N/A | |
30 | 00643169662988 | X0815035 | RETRACTOR X0815035 22MMX5CM ANG TUBULAR | GAD | RETRACTOR | 1 | n/a | |
31 | 00643169591431 | EX0115004 | BAR EX0115004 T | HWT | TEMPLATE | 1 | N/A | |
32 | 00643169546875 | 9735468 | TAPS MODULE SET 9735468 MODULE AND LID | OLO | Orthopedic stereotaxic instrument | 2 | N/A | |
33 | 00643169526013 | X0614034 | INSERTER X0614034 GRAFT | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | N/A | |
34 | 00643169453487 | EX0114070 | FORK EX0114070 ALIGNMENT | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | N/A | |
35 | 00643169442047 | X1113036 | SPREADER X1113036 6MM CAM | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | N/A | |
36 | 00643169400238 | EX0713147 | DISTRACTOR EX0713147 5MM | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | N/A | |
37 | 00643169347878 | 3004986 | TEMPLATE 3004986 ZEVO 86MM 4 LVL | HWT | TEMPLATE | 1 | N/A | |
38 | 00643169328358 | 3004967 | TEMPLATE 3004967 ZEVO 67MM 4 LVL | HWT | TEMPLATE | 1 | N/A | |
39 | 00643169290204 | 5485914 | HANDLE 5485914 ARI LATERAL HANDLE | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | N/A | |
40 | 00643169273542 | EX0812922 | COUNTER EX0812922 TORQUE 5.5/6.0 CLOSED | HXC,LXH | WRENCH,Orthopedic manual surgical instrument | 1 | n/a | |
41 | 00643169272842 | 5619013 | TEMPLATE 5619013 6.0X6.9MM PK RD90-130MM | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | N/A | |
42 | 00643169246775 | EX0812928 | SPREADER EX0812928 LAMINAR | LXH | Orthopedic manual surgical instrument | 1 | n/a | |
43 | 00643169029170 | 5584134 | REDUCER 5584134 CDHS 5.5/6.0 BEALE SLOTS | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | N/A | |
44 | 00643169027046 | EX0511080 | RASP EX0511080 BAYONET HEAD 8MM X 20MM | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | N/A | |
45 | 00643169019942 | 7069039 | LID 7069039 CDHS 5.5/6.0 SET SCREW MOD | FSM | TRAY, SURGICAL, INSTRUMENT | 1 | N/A | |
46 | 00613994993816 | 7069034 | TRAY 7069034 CDHS 5.5 INSTRUMENT 3 LOWER | FSM | TRAY, SURGICAL, INSTRUMENT | 1 | N/A | |
47 | 00613994980045 | 7069001 | TRAY 7069001 SEXTANT RODS | FSM | TRAY, SURGICAL, INSTRUMENT | 1 | N/A | |
48 | 00613994946614 | 5484338 | STARTER 5484338 NON-BREAKOFF PLUG | HXX | SCREWDRIVER | 1 | N/A | |
49 | 00613994888372 | 9396009 | TRAY 9396009 INSTTRAY3 | MQP | SPINAL VERTEBRAL BODY REPLACEMENT DEVICE | 2 | N/A | |
50 | 00613994880390 | 1855121 | LID 1855121 4.75 OUS EXTRA SCRW MOD LID | FSM | TRAY, SURGICAL, INSTRUMENT | 1 | N/A |
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 |