No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 10889981069315 | 41-8055-1 | 41-8055-1 | Solid Screw 8.00 x 55mm | MNI,NKB,KWQ,MNH | ORTHOSIS, SPINAL PEDICLE FIXATION,Orthosis, spinal pedicle fixation, for degener ORTHOSIS, SPINAL PEDICLE FIXATION,Orthosis, spinal pedicle fixation, for degenerative disc disease,APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY,Orthosis, spondylolisthesis spinal fixation | 2 | Mariner |
2 | 10889981157302 | SR-0223-22 | SR-0223-22 | Cambria Trial without Depth Stop | HWT | TEMPLATE | 1 | Specials |
3 | 10889981068042 | 41-6085-2 | 41-6085-2 | Cannulated Screw 6.00 x 85mm | NKB,MNI,KWQ,MNH | Orthosis, spinal pedicle fixation, for degenerative disc disease,ORTHOSIS, SPINA Orthosis, spinal pedicle fixation, for degenerative disc disease,ORTHOSIS, SPINAL PEDICLE FIXATION,APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY,Orthosis, spondylolisthesis spinal fixation | 2 | Mariner |
4 | 10889981067960 | 41-6065-2 | 41-6065-2 | Cannulated Screw 6.00 x 65mm | MNH,NKB,MNI,KWQ | Orthosis, spondylolisthesis spinal fixation,Orthosis, spinal pedicle fixation, f Orthosis, spondylolisthesis spinal fixation,Orthosis, spinal pedicle fixation, for degenerative disc disease,ORTHOSIS, SPINAL PEDICLE FIXATION,APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY | 2 | Mariner |
5 | 10889981067892 | 41-6050-1 | 41-6050-1 | Solid Screw 6.00 x 50mm | KWQ,MNH,NKB,MNI | APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY,Orthosis, spondylolisthesis spin APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY,Orthosis, spondylolisthesis spinal fixation,Orthosis, spinal pedicle fixation, for degenerative disc disease,ORTHOSIS, SPINAL PEDICLE FIXATION | 2 | Mariner |
6 | 10889981067885 | 41-6045-2 | 41-6045-2 | Cannulated Screw 6.00 x 45mm | MNI,MNH,NKB,KWQ | ORTHOSIS, SPINAL PEDICLE FIXATION,Orthosis, spondylolisthesis spinal fixation,Or ORTHOSIS, SPINAL PEDICLE FIXATION,Orthosis, spondylolisthesis spinal fixation,Orthosis, spinal pedicle fixation, for degenerative disc disease,APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY | 2 | Mariner |
7 | 10889981285814 | 86-1107 | 86-1107 | Trial 16x12x7mm, 7 Deg Lordosis, w/ Depth Stop | HWT | TEMPLATE | 1 | Shoreline ACS |
8 | 10889981272678 | SR-0589 | SR-0589 | Outrigger Compressor | HWN | INSTRUMENT, COMPRESSION | 1 | Specials |
9 | 10889981273446 | SR-0654 | SR-0654 | Driver Sleeve | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | Specials |
10 | 10889981269395 | SR-0632 | SR-0632 | Tab Remover | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | Specials |
11 | 10889981257347 | SR-0575 | SR-0575 | Pedicle Marker | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | Specials |
12 | 10889981247683 | AP2-990004 | AP2-990004 | Streamline Handle, Orange, Spin Top | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | Admiral |
13 | 10889981217143 | RA3-009003 | RA3-009003 | Inline Anchor & Screw Caddy | 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 | Meridian |
14 | 10889981213022 | TA2-006000 | TA2-006000 | Graft Block | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | Reef TA |
15 | 10889981212483 | MM2-100270 | MM2-100270 | MIS Rod Inserter | OLO,KWQ,NKB | Orthopedic stereotaxic instrument,Appliance, fixation, spinal intervertebral bod Orthopedic stereotaxic instrument,Appliance, fixation, spinal intervertebral body,Thoracolumbosacral pedicle screw system | 2 | Mariner MIS |
16 | 10889981206369 | TO2-928074 | TO2-928074 | Trial, 9mm x 28mm x 7mm, 5 Deg | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | Reef TO |
17 | 10889981195885 | MC3-900020 | MC3-900020 | Mariner Midline Shank Caddy | OJH | Orthopedic tray | 1 | Mariner MCT |
18 | 10889981178567 | 91-9617 | 91-9617 | NewPort MIS Rod Caddy | OJH | Orthopedic tray | 1 | NewPort™ |
19 | 10889981176396 | SR-0328-30 | SR-0328-30 | Open Body | HXW | BENDER | 1 | Specials |
20 | 10889981174774 | SR-0405 | SR-0405 | 90 DEG Curette | HTF | CURETTE | 1 | Specials |
21 | 10889981171957 | SR-0130-01 | SR-0130-01 | Short 3mm DLTA Driver, A/O | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | Specials |
22 | 10889981115357 | 26-07-0372 | 26-07-0372 | 72mm | KWQ | Appliance, fixation, spinal intervertebral body | 2 | Cordant |
23 | 10889981115326 | 26-07-0363 | 26-07-0363 | 63mm | KWQ | Appliance, fixation, spinal intervertebral body | 2 | Cordant |
24 | 10889981097332 | 95-5716 | 95-5716 | Mask, 16mm | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | Zuma |
25 | 10889981097325 | 95-5714 | 95-5714 | Mask, 14mm | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | Zuma |
26 | 10889981160067 | 33-40-0142 | 33-40-0142 | Graft Block | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | Vu aPOD™ Prime NanoMetalene® |
27 | 10889987170695 | MC2-004090 | MC2-004090 | Rod Holder | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | Mariner MCT |
28 | 10889987170305 | MC2-004110 | MC2-004110 | Counter Torque, Slim | NKB | Thoracolumbosacral pedicle screw system | 2 | Mariner MCT |
29 | 10889987170299 | MC2-004100 | MC2-004100 | Compressor, Slim | HWN | INSTRUMENT, COMPRESSION | 1 | Mariner MCT |
30 | 10889987170282 | MC2-004080 | MC2-004080 | Rod Measurement Wand | HTJ | GAUGE, DEPTH | 1 | Mariner MCT |
31 | 10889987170275 | MC2-004052 | MC2-004052 | Slim Head Inserter, Long | NKB | Thoracolumbosacral pedicle screw system | 2 | Mariner MCT |
32 | 10889987170268 | MC2-004051 | MC2-004051 | Slim Head Inserter, Short | NKB | Thoracolumbosacral pedicle screw system | 2 | Mariner MCT |
33 | 10889987170244 | MC2-004013 | MC2-004013 | Face-cutting Reamer, T-Handle | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | Mariner MCT |
34 | 10889987170237 | MC2-004012 | MC2-004012 | Face-cutting Reamer, Tri-flat | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | Mariner MCT |
35 | 10889987170220 | MC2-004011 | MC2-004011 | Face-cutting Reamer, A/O | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | Mariner MCT |
36 | 10889987170213 | MC2-004010 | MC2-004010 | Face-cutting Reamer, 1/4"Quick-connect | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | Mariner MCT |
37 | 10889987170206 | MC2-003042 | MC2-003042 | 4.0mm Drill, Solid, Tri-Flat | HTW | BIT, DRILL | 1 | Mariner MCT |
38 | 10889987170190 | MC2-003041 | MC2-003041 | 4.0mm Drill, Solid, A/O QC | HTW | BIT, DRILL | 1 | Mariner MCT |
39 | 10889987170183 | MC2-003040 | MC2-003040 | 4.0mm Drill, Solid, 1/4" QC | HTW | BIT, DRILL | 1 | Mariner MCT |
40 | 10889987170176 | MC2-003037 | MC2-003037 | 3.5mm Drill, Solid, Tri-Flat | HTW | BIT, DRILL | 1 | Mariner MCT |
41 | 10889987170169 | MC2-003036 | MC2-003036 | 3.5mm Drill, Solid, A/O QC | HTW | BIT, DRILL | 1 | Mariner MCT |
42 | 10889987170152 | MC2-003035 | MC2-003035 | 3.5mm Drill, Solid, 1/4" QC | HTW | BIT, DRILL | 1 | Mariner MCT |
43 | 10889987170145 | MC2-003032 | MC2-003032 | 3.0mm Drill, Solid, Tri-Flat | HTW | BIT, DRILL | 1 | Mariner MCT |
44 | 10889987170138 | MC2-003031 | MC2-003031 | 3.0mm Drill, Solid, A/O QC | HTW | BIT, DRILL | 1 | Mariner MCT |
45 | 10889987170121 | MC2-003030 | MC2-003030 | 3.0mm Drill, Solid, 1/4" QC | HTW | BIT, DRILL | 1 | Mariner MCT |
46 | 10889987170114 | MC2-003012 | MC2-003012 | Cortical Screw Shank Driver, Long | NKB | Thoracolumbosacral pedicle screw system | 2 | Mariner MCT |
47 | 10889987170107 | MC2-003011 | MC2-003011 | Cortical Screw Shank Driver, Short | NKB | Thoracolumbosacral pedicle screw system | 2 | Mariner MCT |
48 | 10889987170091 | MC2-003010 | MC2-003010 | Cortical Screw Shank Driver | NKB | Thoracolumbosacral pedicle screw system | 2 | Mariner MCT |
49 | 10889987170084 | MC2-002065 | MC2-002065 | 6.5mm Tap, Cortical, Cannulated | HWX | TAP, BONE | 1 | Mariner MCT |
50 | 10889987170077 | MC2-002060 | MC2-002060 | 6.0mm Tap, Cortical, Cannulated | HWX | TAP, BONE | 1 | Mariner MCT |
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 |