No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 03663136024196 | TL1-A009 | Graft Funnell | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | NA | |
2 | 03663136033433 | SD-RACK1 | Screws Rack | KWQ,KWP,MNI,MNH | Appliance, Fixation, Spinal Intervertebral Body,Appliance, Fixation, Spinal Inte Appliance, Fixation, Spinal Intervertebral Body,Appliance, Fixation, Spinal Interlaminal,Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation | 2 | U.L.I.S™ | |
3 | 03663136033372 | SD-TRAY111 | Pedicle Preparation Tray | KWQ,KWP,MNH,MNI | Appliance, Fixation, Spinal Intervertebral Body,Appliance, Fixation, Spinal Inte Appliance, Fixation, Spinal Intervertebral Body,Appliance, Fixation, Spinal Interlaminal,Orthosis, Spondylolisthesis Spinal Fixation,Orthosis, Spinal Pedicle Fixation | 2 | PLUS™ | |
4 | 03663136033297 | U1-A216 | Rod gripper | KWQ,KWP,MNI,MNH | Appliance, Fixation, Spinal Intervertebral Body,Appliance, Fixation, Spinal Inte Appliance, Fixation, Spinal Intervertebral Body,Appliance, Fixation, Spinal Interlaminal,Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation | 2 | PLUS™ | |
5 | 03663136033426 | IS1-TRAY115 | Tray 5 ULIS | KWQ,KWP,MNI,MNH | Appliance, Fixation, Spinal Intervertebral Body,Appliance, Fixation, Spinal Inte Appliance, Fixation, Spinal Intervertebral Body,Appliance, Fixation, Spinal Interlaminal,Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation | 2 | U.L.I.S™ | |
6 | 03663136032214 | TL3-A022 | Tamp | HXG | Tamp | 1 | Hexanium® TLIF | |
7 | 03663136030623 | SPL1-OC10-26 | Sterile OLIF cage H10-L26 | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | SpaceVision® OLIF | |
8 | 03663136025667 | U1-MRODB | ST ROD INSERT | FSM | TRAY, SURGICAL, INSTRUMENT | 1 | P.L.U.S.® | |
9 | 03663136025650 | U1-MROD | ST ROD MODULE | FSM | TRAY, SURGICAL, INSTRUMENT | 1 | P.L.U.S.® | |
10 | 03663136024691 | U1-A122L | SPATULA, Long | HXR | SPATULA, ORTHOPEDIC | 1 | P.L.U.S.® | |
11 | 03663136005324 | L2-L975T | 7.5mm Ti Offset Connector | MNI,MNH | ORTHOSIS, SPINAL PEDICLE FIXATION,Orthosis, spondylolisthesis spinal fixation | 2 | UNI-THREAD® | |
12 | 03663136001135 | AC2-A010 | Rasp | LXH | Orthopedic Manual Surgical Instrument | 1 | Hexanium® ACIF | |
13 | 03663136000060 | U1-RACKVIS2 | Plus Big Screws Rack | KWQ,KWP,MNH,MNI | Appliance, Fixation, Spinal Intervertebral Body,Appliance, Fixation, Spinal Inte Appliance, Fixation, Spinal Intervertebral Body,Appliance, Fixation, Spinal Interlaminal,Orthosis, Spondylolisthesis Spinal Fixation,Orthosis, Spinal Pedicle Fixation | 2 | PLUS | |
14 | 03663136024202 | TL1-A010-07 | Template H07 | HWT | TEMPLATE | 1 | NA | |
15 | 03663136024189 | TL1-A007 | Cage Support/T | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | NA | |
16 | 03663136033242 | TL3-CS16 | Ti TLIF Cage Small H16 mm | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Hexanium® TLIF | |
17 | 03663136024172 | TL1-A006 | Graft Impactor/T | HWA | IMPACTOR | 1 | NA | |
18 | 03663136033235 | TL3-CS15 | Ti TLIF Cage Small H15 mm | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Hexanium® TLIF | |
19 | 03663136023922 | PL1-A008N1 | Cage Holder/P | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | NA | |
20 | 03663136023915 | PL1-A007 | Sliding Hammer | FZY | HAMMER, SURGICAL | 1 | NA | |
21 | 03663136033228 | TL3-CS14 | Ti TLIF Cage Small H14 mm | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Hexanium® TLIF | |
22 | 03663136033211 | TL3-CS13 | Ti TLIF Cage Small H13 mm | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Hexanium® TLIF | |
23 | 03663136031958 | TL3-A011-07 | Reamer 07 | HTO | Reamer | 1 | Hexanium® TLIF | |
24 | 03663136033273 | TL3-TRAY113 | Ti TLIF Instruments Tray | LXH | Orthopedic Manual Surgical Instrument | 1 | Hexanium® TLIF | |
25 | 03663136033266 | TL3-A012 | Ti TLIF Cage Trial Holder | HXK | Holder, Needle; Orthopedic | 1 | Hexanium® TLIF | |
26 | 03663136033259 | SD-ATSH1169214C5 | Snap-On Cannulated Silicon T-Handle | LXH | Orthopedic Manual Surgical Instrument | 1 | Hexanium® TLIF | |
27 | 03663136033204 | TL3-CS12 | Ti TLIF Cage Small H12 mm | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Hexanium® TLIF | |
28 | 03663136033198 | TL3-CS11 | Ti TLIF Cage Small H11 mm | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Hexanium® TLIF | |
29 | 03663136033181 | TL3-CS10 | Ti TLIF Cage Small H10 mm | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Hexanium® TLIF | |
30 | 03663136033174 | TL3-CS09 | Ti TLIF Cage Small H09 mm | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Hexanium® TLIF | |
31 | 03663136033167 | TL3-CS08 | Ti TLIF Cage Small H08 mm | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Hexanium® TLIF | |
32 | 03663136033150 | TL3-CS07 | Ti TLIF Cage Small H07 mm | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Hexanium® TLIF | |
33 | 03663136033143 | TL3-CM16 | Ti TLIF Cage Medium H16 mm | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Hexanium® TLIF | |
34 | 03663136033136 | TL3-CM15 | Ti TLIF Cage Medium H15 mm | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Hexanium® TLIF | |
35 | 03663136033129 | TL3-CM14 | Ti TLIF Cage Medium H14 mm | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Hexanium® TLIF | |
36 | 03663136033112 | TL3-CM13 | Ti TLIF Cage Medium H13 mm | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Hexanium® TLIF | |
37 | 03663136033105 | TL3-CM12 | Ti TLIF Cage Medium H12 mm | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Hexanium® TLIF | |
38 | 03663136033099 | TL3-CM11 | Ti TLIF Cage Medium H11 mm | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Hexanium® TLIF | |
39 | 03663136033082 | TL3-CM10 | Ti TLIF Cage Medium H10 mm | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Hexanium® TLIF | |
40 | 03663136033075 | TL3-CM09 | Ti TLIF Cage Medium H09 mm | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Hexanium® TLIF | |
41 | 03663136033068 | TL3-CM08 | Ti TLIF Cage Medium H08 mm | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Hexanium® TLIF | |
42 | 03663136033051 | TL3-CM07 | Ti TLIF Cage Medium H07 mm | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Hexanium® TLIF | |
43 | 03663136032658 | L2-R613HT | Rigid rod 6.0 mm x 130 mm | MNI,MNH | Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation | 2 | UNI-THREAD™ | |
44 | 03663136032641 | L2-R611HT | Rigid rod 6.0 mm x 110 mm | MNI,MNH | Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation | 2 | UNI-THREAD™ | |
45 | 03663136032467 | SPL1-C13-29-04 | Sterile PLIF cage H13-L29-A04 | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | SpaceVision® PLIF | |
46 | 03663136032443 | PL1-A012-13 | Trial device 13 | LXH | Orthopedic Manual Surgical Instrument | 1 | NA | |
47 | 03663136032412 | TL3-A010-15 | Spreader 15 | LXH | Orthopedic Manual Surgical Instrument | 1 | Hexanium® TLIF | |
48 | 03663136032405 | TL3-A013-S15 | Ti TLIF Cage Trial Small 15 | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | Hexanium® TLIF | |
49 | 03663136032399 | TL3-A011-16 | Reamer 16 | HTO | Reamer | 1 | Hexanium® TLIF | |
50 | 03663136032382 | TL3-A011-15 | Reamer 15 | HTO | Reamer | 1 | Hexanium® TLIF |
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 |