No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00840019910224 | 26-221000-12 | 26-221000-12 | Wide PLIF Cage Peek 0 degree 22 x 10 X 12 | KWQ,MAX | Appliance, Fixation, Spinal Intervertebral Body,Intervertebral Fusion Device Wit Appliance, Fixation, Spinal Intervertebral Body,Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | ShurFit Interbody Deviceem |
2 | 00840019926027 | 43-2100-00 | 43-2100-00 | Medial Blade Rack Assembly | GAD | Retractor | 1 | MD-Max ULIF |
3 | 00840019932684 | 62-BK-0103 | 62-BK-0103 | ACIF 2C Instrument BOM | ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 2 | ShurFit ACIF 2C |
4 | 00840019932677 | 62-BK-0102 | 62-BK-0102 | ACIF 2C Instrument BOM | ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 2 | ShurFit ACIF 2C |
5 | 00840019937191 | 39-BK-0703 | 39-BK-0703 | Implant Kit: Std + Red (Ti) | MNH,MNI | Orthosis, Spondylolisthesis Spinal Fixation,Orthosis, Spinal Pedicle Fixation | 2 | Implant Kit: Std + Red (Ti) |
6 | 00840019932660 | 62-BK-0101 | 62-BK-0101 | ACIF 2C Instrument BOM | ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 2 | ShurFit ACIF 2C |
7 | 00840019936972 | 43-8700-CA | 43-8700-CA | MD-Max™ Pedicle Screw System Kit | MNI,MNH | Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation | 2 | MD-Max ULIF |
8 | 00840019936965 | 43-8600-CA | 43-8600-CA | MD-Max™ Triple Lead System Implant Case | MNH,MNI | Orthosis, Spondylolisthesis Spinal Fixation,Orthosis, Spinal Pedicle Fixation | 2 | MD-Max ULIF |
9 | 00840019936958 | 43-8500-CA | 43-8500-CA | MD-Max™ Implant Kit | MNI,MNH | Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation | 2 | MD-Max ULIF |
10 | 00840019936941 | 43-8200-CA | 43-8200-CA | MD-Max™ Triple Lead MIS Instrument Kit | MNI,MNH | Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation | 2 | MD-Max ULIF |
11 | 00840019936934 | 43-8100-CA | 43-8100-CA | MD-Max™ Triple Lead System Instrument Case | MNI,MNH | Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation | 2 | MD-Max ULIF |
12 | 00840019936927 | 43-8000-CA | 43-8000-CA | MD-Max™ ULIF Retractor Instrument Kit | MNI,MNH | Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation | 2 | MD-Max ULIF |
13 | 00840019932707 | ACIFXX-XXP-2C-CC | ACIFXX-XXP-2C-CC | ACIF 2C Wide Kit Case BOM | ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 2 | ShurFit ACIF 2C |
14 | 00840019932691 | 62-BK-0601 | 62-BK-0601 | ACIF 2C Wide Kit Case BOM | ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 2 | ShurFit ACIF 2C |
15 | 00840019926089 | 43-5000 | 43-5000 | Lumitex Light Source | LXH | Orthopedic Manual Surgical Instrument | 1 | MD-Max ULIF |
16 | 00840019926218 | 43-8700 | 43-8700 | MD-Max™ Pedicle Screw System Case - Empty | MNI,MNH | Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation | 2 | MD-Max ULIF |
17 | 00840019926201 | 43-8600 | 43-8600 | MD-Max™ Triple Lead System Implant Tray - Empty | MNH,MNI | Orthosis, Spondylolisthesis Spinal Fixation,Orthosis, Spinal Pedicle Fixation | 2 | MD-Max ULIF |
18 | 00840019926195 | 43-8550 | 43-8550 | MD-Max™ Implant Case - Empty | MNI,MNH | Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation | 2 | MD-Max ULIF |
19 | 00840019926188 | 43-8200 | 43-8200 | MD-Max™ Triple Lead MIS Instrument Case - Empty | MNI,MNH | Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation | 2 | MD-Max ULIF |
20 | 00840019926171 | 43-8100 | 43-8100 | MD-Max™ Triple Lead System Instrument Tray - Empty | MNI,MNH | Orthosis, Spinal Pedicle Fixation,Orthosis, Spondylolisthesis Spinal Fixation | 2 | MD-Max ULIF |
21 | 00840019926164 | 43-8050 | 43-8050 | MD-Max™ ULIF Retractor Instrument Case - Empty | MNH,MNI | Orthosis, Spondylolisthesis Spinal Fixation,Orthosis, Spinal Pedicle Fixation | 2 | MD-Max ULIF |
22 | 00840019926157 | 48-9018 | 48-9018 | MD-Max Bottle Cap Reducer | LXH | Orthopedic Manual Surgical Instrument | 1 | MD-Max ULIF |
23 | 00840019926140 | 43-6200 | 43-6200 | Contralateral Sleeve Assembly | GAD | Retractor | 1 | MD-Max ULIF |
24 | 00840019926133 | 43-6100-100 | 43-6100-100 | Ipsilateral Sleeve Assembly, 100mm | GAD | Retractor | 1 | MD-Max ULIF |
25 | 00840019926126 | 43-6100-080 | 43-6100-080 | Ipsilateral Sleeve Assembly, 80mm | GAD | Retractor | 1 | MD-Max ULIF |
26 | 00840019926119 | 43-6100-060 | 43-6100-060 | Ipsilateral Sleeve Assembly, 60mm | GAD | Retractor | 1 | MD-Max ULIF |
27 | 00840019926102 | 43-6100-040 | 43-6100-040 | Ipsilateral Sleeve Assembly, 40mm | GAD | Retractor | 1 | MD-Max ULIF |
28 | 00840019926096 | 43-6000 | 43-6000 | Bilateral Retractor Assembly | GAD | Retractor | 1 | MD-Max ULIF |
29 | 00840019926072 | 43-4100-85 | 43-4100-85 | 8.5mm MD-Max Triple Lead Tap | HWX | Tap, Bone | 1 | MD-Max ULIF |
30 | 00840019926065 | 43-4100-75 | 43-4100-75 | 7.5mm MD-Max™ Triple Lead Tap | HWX | Tap, Bone | 1 | MD-Max ULIF |
31 | 00840019926058 | 43-4100-65 | 43-4100-65 | 6.5mm MD-Max™ Triple Lead Tap | HWX | Tap, Bone | 1 | MD-Max ULIF |
32 | 00840019926041 | 43-4100-55 | 43-4100-55 | 5.5mm MD-Max™ Triple Lead Tap | HWX | Tap, Bone | 1 | MD-Max ULIF |
33 | 00840019926034 | 43-2200-00 | 43-2200-00 | Medial Blade Bar | GAD | Retractor | 1 | MD-Max ULIF |
34 | 00840019926010 | 43-2000-110 | 43-2000-110 | Medial Retractor Blade, 110 mm | GAD | Retractor | 1 | MD-Max ULIF |
35 | 00840019926003 | 43-2000-100 | 43-2000-100 | Medial Retractor Blade, 100 mm | GAD | Retractor | 1 | MD-Max ULIF |
36 | 00840019925990 | 43-2000-090 | 43-2000-090 | Medial Retractor Blade, 90 mm | GAD | Retractor | 1 | MD-Max ULIF |
37 | 00840019925983 | 43-2000-080 | 43-2000-080 | Medial Retractor Blade, 80 mm | GAD | Retractor | 1 | MD-Max ULIF |
38 | 00840019925976 | 43-2000-070 | 43-2000-070 | Medial Retractor Blade, 70 mm | GAD | Retractor | 1 | MD-Max ULIF |
39 | 00840019925969 | 43-2000-060 | 43-2000-060 | Medial Retractor Blade, 60 mm | GAD | Retractor | 1 | MD-Max ULIF |
40 | 00840019925952 | 43-2000-050 | 43-2000-050 | Medial Retractor Blade, 50 mm | GAD | Retractor | 1 | MD-Max ULIF |
41 | 00840019925945 | 43-2000-040 | 43-2000-040 | Medial Retractor Blade, 40 mm | GAD | Retractor | 1 | MD-Max ULIF |
42 | 00840019925938 | 43-1629 | 43-1629 | Hexdriver | HXX | Screwdriver | 1 | MD-Max ULIF |
43 | 00840019925921 | 43-1545 | 43-1545 | Drill, Pedicle Targeting | HTW | Bit, Drill | 1 | MD-Max ULIF |
44 | 00840019925907 | 43-0552 | 43-0552 | Torque Limiting T-Handle 36 in-lbs | LXH | Orthopedic Manual Surgical Instrument | 1 | MD-Max ULIF |
45 | 00840019925891 | 43-0080 | 43-0080 | Reusable Light Cable-Lumitex | LXH | Orthopedic Manual Surgical Instrument | 1 | MD-Max ULIF |
46 | 00840019921077 | 62-NR-5007 | 62-NR-5007 | ACIF Rasp, 18 x 15 x 7 | HTR | Rasp | 1 | ShurFit ACIF 2C |
47 | 00840019921428 | 62-TN-1815-10 | 62-TN-1815-10 | ACIF Trial, 18 x 15 x 10 | HWT | Template | 1 | ShurFit ACIF 2C |
48 | 00840019921060 | 62-NR-5006 | 62-NR-5006 | ACIF Rasp, 18 x 15 x 6 | HTR | Rasp | 1 | ShurFit ACIF 2C |
49 | 00840019921480 | 62-SC-0103 | 62-SC-0103 | ACIF 2C Instrument Case - Expanded | ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 2 | ShurFit ACIF 2C |
50 | 00840019921473 | 62-SC-0102 | 62-SC-0102 | ACIF 2C Instrument Case - Expanded + Double Wide | ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 2 | ShurFit ACIF 2C |
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 |