No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | M9935071730 | 507173 | Rod Reducer | LXH | Orthopedic Manual Surgical Instrument | 1 | GSO PCT Spinal System | |
2 | M9935071710 | 507171 | Compressor | LXH | Orthopedic Manual Surgical Instrument | 1 | GSO PCT Spinal System | |
3 | M9935071810 | 507181 | Instrument Case | LRP | Tray, Surgical | 1 | GSO PCT Spinal System | |
4 | M9935071800 | 507180 | Implant Instrument Case | LRP | Tray, Surgical | 1 | GSO PCT Spinal System | |
5 | M9935071770 | 507177 | Right PCT In-Situ Rod Bender | HXP | Instrument, Bending Or Contouring | 1 | GSO PCT Spinal System | |
6 | M9935071760 | 507176 | Left PCT In-Situ Rod Bender | HXP | Instrument, Bending Or Contouring | 1 | GSO PCT Spinal System | |
7 | M9935071740 | 507174 | Nut Driver | LXH | Orthopedic Manual Surgical Instrument | 1 | GSO PCT Spinal System | |
8 | M9935071700 | 507170 | Distractor | LXH | Orthopedic Manual Surgical Instrument | 1 | GSO PCT Spinal System | |
9 | M9935071690 | 507169 | Anti-Torque Device | LXH | Orthopedic Manual Surgical Instrument | 1 | GSO PCT Spinal System | |
10 | M9935071680 | 507168 | Set Screw Starter | LXH | Orthopedic Manual Surgical Instrument | 1 | GSO PCT Spinal System | |
11 | M9935071660 | 507166 | Rod Cutter | LXH | Orthopedic Manual Surgical Instrument | 1 | GSO PCT Spinal System | |
12 | M9935071650 | 507165 | Rod Bender | HXP | Instrument, Bending Or Contouring | 1 | GSO PCT Spinal System | |
13 | M9935071630 | 507163 | Rod Holder | LXH | Orthopedic Manual Surgical Instrument | 1 | GSO PCT Spinal System | |
14 | M9935071620 | 507162 | Multi-Axial Screw Driver | LXH | Orthopedic Manual Surgical Instrument | 1 | GSO PCT Spinal System | |
15 | M9935071610 | 507161 | 2.5mm Driver Bit | LXH | Orthopedic Manual Surgical Instrument | 1 | GSO PCT Spinal System | |
16 | M9935071600 | 507159 | Bone Screw Tap | HWX | Tap, Bone | 1 | GSO PCT Spinal System | |
17 | M9935071590 | 507159 | Bone Screw Tap | HWX | Tap, Bone | 1 | GSO PCT Spinal System | |
18 | M9935071580 | 507158 | Bone Screw Tap | HWX | Tap, Bone | 1 | GSO PCT Spinal System | |
19 | M993507155120 | 50715512 | 12mm Drill Guide Extension | LXH | Orthopedic Manual Surgical Instrument | 1 | GSO PCT Spinal System | |
20 | M9935071550 | 507155 | Drill Guide | LXH | Orthopedic Manual Surgical Instrument | 1 | GSO PCT Spinal System | |
21 | M9935071540 | 507154 | Bone Awl Assembly | HWJ | Awl | 1 | GSO PCT Spinal System | |
22 | M9935071530 | 507153 | Torque Limiting Set Screw Driver | LXH | Orthopedic Manual Surgical Instrument | 1 | GSO PCT Spinal System | |
23 | M9935071520 | 507152 | Quick Connect Handle | LXH | Orthopedic Manual Surgical Instrument | 1 | GSO PCT Spinal System | |
24 | M9935071500 | 507150 | Straight Sounding Probe | HXB | Probe | 1 | GSO PCT Spinal System | |
25 | M9935071280 | 507128 | Head Aligner / Rod Pusher | LXH | Orthopedic Manual Surgical Instrument | 1 | GSO PCT Spinal System | |
26 | M9935071050 | 507105 | Drill | HTW | Bit, Drill | 1 | GSO PCT Spinal System | |
27 | M9935066501 | 506650 | Smooth Shank Multi-Axial Screw | KWP | Appliance, Fixation, Spinal Interlaminal | 2 | GSO PCT Spinal System | |
28 | M9935066500 | 506650 | Smooth Shank Multi-Axial Screw | KWP | Appliance, Fixation, Spinal Interlaminal | 2 | GSO PCT Spinal System | |
29 | M9935066481 | 506648 | Smooth Shank Multi-Axial Screw | KWP | Appliance, Fixation, Spinal Interlaminal | 2 | GSO PCT Spinal System | |
30 | M9935066480 | 506648 | Smooth Shank Multi-Axial Screw | KWP | Appliance, Fixation, Spinal Interlaminal | 2 | GSO PCT Spinal System | |
31 | M9935066461 | 506646 | Smooth Shank Multi-Axial Screw | KWP | Appliance, Fixation, Spinal Interlaminal | 2 | GSO PCT Spinal System | |
32 | M9935066460 | 506646 | Smooth Shank Multi-Axial Screw | KWP | Appliance, Fixation, Spinal Interlaminal | 2 | GSO PCT Spinal System | |
33 | M9935066441 | 506644 | Smooth Shank Multi-Axial Screw | KWP | Appliance, Fixation, Spinal Interlaminal | 2 | GSO PCT Spinal System | |
34 | M9935066440 | 506644 | Smooth Shank Multi-Axial Screw | KWP | Appliance, Fixation, Spinal Interlaminal | 2 | GSO PCT Spinal System | |
35 | M9935066421 | 506642 | Smooth Shank Multi-Axial Screw | KWP | Appliance, Fixation, Spinal Interlaminal | 2 | GSO PCT Spinal System | |
36 | M9935066420 | 506642 | Smooth Shank Multi-Axial Screw | KWP | Appliance, Fixation, Spinal Interlaminal | 2 | GSO PCT Spinal System | |
37 | M9935066401 | 506640 | Smooth Shank Multi-Axial Screw | KWP | Appliance, Fixation, Spinal Interlaminal | 2 | GSO PCT Spinal System | |
38 | M9935066400 | 506640 | Smooth Shank Multi-Axial Screw | KWP | Appliance, Fixation, Spinal Interlaminal | 2 | GSO PCT Spinal System | |
39 | M9935066381 | 506638 | Smooth Shank Multi-Axial Screw | KWP | Appliance, Fixation, Spinal Interlaminal | 2 | GSO PCT Spinal System | |
40 | M9935066380 | 506638 | Smooth Shank Multi-Axial Screw | KWP | Appliance, Fixation, Spinal Interlaminal | 2 | GSO PCT Spinal System | |
41 | M9935066361 | 506636 | Smooth Shank Multi-Axial Screw | KWP | Appliance, Fixation, Spinal Interlaminal | 2 | GSO PCT Spinal System | |
42 | M9935066360 | 506636 | Smooth Shank Multi-Axial Screw | KWP | Appliance, Fixation, Spinal Interlaminal | 2 | GSO PCT Spinal System | |
43 | M9935066341 | 506634 | Smooth Shank Multi-Axial Screw | KWP | Appliance, Fixation, Spinal Interlaminal | 2 | GSO PCT Spinal System | |
44 | M9935066340 | 506634 | Smooth Shank Multi-Axial Screw | KWP | Appliance, Fixation, Spinal Interlaminal | 2 | GSO PCT Spinal System | |
45 | M9935066321 | 506632 | Smooth Shank Multi-Axial Screw | KWP | Appliance, Fixation, Spinal Interlaminal | 2 | GSO PCT Spinal System | |
46 | M9935066320 | 506632 | Smooth Shank Multi-Axial Screw | KWP | Appliance, Fixation, Spinal Interlaminal | 2 | GSO PCT Spinal System | |
47 | M9935066301 | 506630 | Smooth Shank Multi-Axial Screw | KWP | Appliance, Fixation, Spinal Interlaminal | 2 | GSO PCT Spinal System | |
48 | M9935066300 | 506630 | Smooth Shank Multi-Axial Screw | KWP | Appliance, Fixation, Spinal Interlaminal | 2 | GSO PCT Spinal System | |
49 | M9935066281 | 506628 | Smooth Shank Multi-Axial Screw | KWP | Appliance, Fixation, Spinal Interlaminal | 2 | GSO PCT Spinal System | |
50 | M9935066280 | 506628 | Smooth Shank Multi-Axial Screw | KWP | Appliance, Fixation, Spinal Interlaminal | 2 | GSO PCT Spinal System |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00813892021073 | CN3010 | CN3010 | Cross Link Nut | Outologous Spinal Fixation System | ORTHOPEDIC SCIENCES INC |
2 | 00813892021066 | CH2010 | CH2010 | Cross Link Hook | Outologous Spinal Fixation System | ORTHOPEDIC SCIENCES INC |
3 | 00813892021059 | TL1080 | TL1080 | 80mm Cross Link | Outologous Spinal Fixation System | ORTHOPEDIC SCIENCES INC |
4 | 00813892021042 | TL1070 | TL1070 | 70mm Cross Link | Outologous Spinal Fixation System | ORTHOPEDIC SCIENCES INC |
5 | 00813892021035 | TL1060 | TL1060 | 60mm Cross Link | Outologous Spinal Fixation System | ORTHOPEDIC SCIENCES INC |
6 | 00813892021028 | TL1050 | TL1050 | 50mm Cross Link | Outologous Spinal Fixation System | ORTHOPEDIC SCIENCES INC |
7 | 00813892021011 | TL1040 | TL1040 | 40mm Cross Link | Outologous Spinal Fixation System | ORTHOPEDIC SCIENCES INC |
8 | 00813892021004 | SS6020 | SS6020 | Set Screw | Outologous Spinal Fixation System | ORTHOPEDIC SCIENCES INC |
9 | 00813892020991 | RD6150 | RD6150 | 6.0 x 150mm Titanium Rod | Outologous Spinal Fixation System | ORTHOPEDIC SCIENCES INC |
10 | 00813892020984 | RD6120 | RD6120 | 6. 0x 120mm Titanium Rod | Outologous Spinal Fixation System | ORTHOPEDIC SCIENCES INC |
11 | 00813892020977 | RD6100 | RD6100 | 6.0 x 100mm Titanium Rod | Outologous Spinal Fixation System | ORTHOPEDIC SCIENCES INC |
12 | 00813892020960 | RD6090 | RD6090 | 6.0 x 90mm Titanium Rod | Outologous Spinal Fixation System | ORTHOPEDIC SCIENCES INC |
13 | 00813892020953 | RD6080 | RD6080 | 6.0 x 80mm Titanium Rod | Outologous Spinal Fixation System | ORTHOPEDIC SCIENCES INC |
14 | 00813892020946 | RD6070 | RD6070 | 6.0 x 70mm Titanium Rod | Outologous Spinal Fixation System | ORTHOPEDIC SCIENCES INC |
15 | 00813892020939 | RD6060 | RD6060 | 6.0 x 60mm Titanium Rod | Outologous Spinal Fixation System | ORTHOPEDIC SCIENCES INC |
16 | 00813892020922 | RD6050 | RD6050 | 6.0 x 50mm Titanium Rod | Outologous Spinal Fixation System | ORTHOPEDIC SCIENCES INC |
17 | 00813892020915 | RD6040 | RD6040 | 6.0 x 40mm Titanium Rod | Outologous Spinal Fixation System | ORTHOPEDIC SCIENCES INC |
18 | 00813892020908 | PS7060 | PS7060 | 7.0 X 60mm Titanium Pedicle Screw Self Tapping | Outologous Spinal Fixation System | ORTHOPEDIC SCIENCES INC |
19 | 00813892020892 | PS7055 | PS7055 | 7.0 X 55mm Titanium Pedicle Screw Self Tapping | Outologous Spinal Fixation System | ORTHOPEDIC SCIENCES INC |
20 | 00813892020885 | PS7050 | PS7050 | 7.0 X 50mm Titanium Pedicle Screw Self Tapping | Outologous Spinal Fixation System | ORTHOPEDIC SCIENCES INC |
21 | 00813892020878 | PS7045 | PS7045 | 7.0 X 45mm Titanium Pedicle Screw Self Tapping | Outologous Spinal Fixation System | ORTHOPEDIC SCIENCES INC |
22 | 00813892020861 | PS7040 | PS7040 | 7.0 X 40mm Titanium Pedicle Screw Self Tapping | Outologous Spinal Fixation System | ORTHOPEDIC SCIENCES INC |
23 | 00813892020854 | PS7035 | PS7035 | 7.0 X 35mm Titanium Pedicle Screw Self Tapping | Outologous Spinal Fixation System | ORTHOPEDIC SCIENCES INC |
24 | 00813892020847 | PS7030 | PS7030 | 7.0 X 30mm Titanium Pedicle Screw Self Tapping | Outologous Spinal Fixation System | ORTHOPEDIC SCIENCES INC |
25 | 00813892020830 | PS6060 | PS6060 | 6.0 X 60mm Titanium Pedicle Screw Self Tapping | Outologous Spinal Fixation System | ORTHOPEDIC SCIENCES INC |
26 | 00813892020823 | PS6055 | PS6055 | 6.0 X 55mm Titanium Pedicle Screw Self Tapping | Outologous Spinal Fixation System | ORTHOPEDIC SCIENCES INC |
27 | 00813892020816 | PS6050 | PS6050 | 6.0 X 50mm Titanium Pedicle Screw Self Tapping | Outologous Spinal Fixation System | ORTHOPEDIC SCIENCES INC |
28 | 00813892020809 | PS6045 | PS6045 | 6.0 X 45mmTitanium Pedicle Screw Self Tapping | Outologous Spinal Fixation System | ORTHOPEDIC SCIENCES INC |
29 | 00813892020793 | PS6040 | PS6040 | 6.0 X 40mm Titanium Pedicle Screw Self Tapping | Outologous Spinal Fixation System | ORTHOPEDIC SCIENCES INC |
30 | 00813892020786 | PS6035 | PS6035 | 6.0 X 35mm Titanium Pedicle Screw Self Tapping | Outologous Spinal Fixation System | ORTHOPEDIC SCIENCES INC |
31 | 00813892020779 | PS6030 | PS6030 | 6.0 X 30mm Titanium Pedicle Screw Self Tapping | Outologous Spinal Fixation System | ORTHOPEDIC SCIENCES INC |
32 | 00813210022300 | 800-0235 | Polyaxial Plate Inserter | primaLOK SP | WENZEL SPINE, INC. | |
33 | 00813210022294 | 800-0233 | Post Plate Inserter | primaLOK SP | WENZEL SPINE, INC. | |
34 | 00813210022287 | 800-0228 | Offset Provisional Locker | primaLOK SP | WENZEL SPINE, INC. | |
35 | 00813210022270 | 800-0227 | Inserter Compressor II | primaLOK SP | WENZEL SPINE, INC. | |
36 | 00813210022263 | 800-0203 | Removal Tool | primaLOK SP | WENZEL SPINE, INC. | |
37 | 00813210022256 | 800-0201 | Lock Ring Compressor | primaLOK SP | WENZEL SPINE, INC. | |
38 | 00813210022249 | 800-0200 | Implant Inserter | primaLOK SP | WENZEL SPINE, INC. | |
39 | 00813210021785 | 800-0828-00 | primaLOK SP 28mm Medium Boxless Implant, Sterile primaLOK SP 28mm Medium Boxless Implant, Sterile The Wenzel Spine primaLOK SP Interspinous Fusion System is a posterior, nonpedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). it is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), and/or tumor. The primaLOK SP Interspinous Fusion System is intended for use at one level with bone graft material and not intended for stand-alone use. | primaLOK SP | WENZEL SPINE, INC. | |
40 | 00813210021778 | 800-0118-00 | primaLOK SP 18mm Implant Assembly, Sterile primaLOK SP 18mm Implant Assembly, Sterile The Wenzel Spine primaLOK SP Interspinous Fusion System is a posterior, nonpedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). it is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), and/or tumor. The primaLOK SP Interspinous Fusion System is intended for use at one level with bone graft material and not intended for stand-alone use. | primaLOK SP | WENZEL SPINE, INC. | |
41 | 00813210021761 | 800-0115-00 | primaLOK SP 15mm Implant Assembly, Sterile primaLOK SP 15mm Implant Assembly, Sterile The Wenzel Spine primaLOK SP Interspinous Fusion System is a posterior, nonpedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). it is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as ack pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), and/or tumor. The primaLOK SP Interspinous Fusion System is intended for use at one level with bone graft material and not intended for stand-alone use. | primaLOK SP | WENZEL SPINE, INC. | |
42 | 00813210021754 | 800-0112-00 | primaLOK SP 12mm Implant Assembly, Sterile primaLOK SP 12mm Implant Assembly, Sterile The Wenzel Spine primaLOK SP Interspinous Fusion System is a posterior, nonpedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). it is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as ack pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), and/or tumor. The primaLOK SP Interspinous Fusion System is intended for use at one level with bone graft material and not intended for stand-alone use. | primaLOK SP | WENZEL SPINE, INC. | |
43 | 00813210021747 | 800-0110-00 | primaLOK SP 10mm Implant Assembly, Sterile primaLOK SP 10mm Implant Assembly, Sterile The Wenzel Spine primaLOK SP Interspinous Fusion System is a posterior, nonpedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). it is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as ack pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), and/or tumor. The primaLOK SP Interspinous Fusion System is intended for use at one level with bone graft material and not intended for stand-alone use. | primaLOK SP | WENZEL SPINE, INC. | |
44 | 00813210021730 | 800-0108-00 | primaLOK SP 8mm Implant Assembly, Sterile primaLOK SP 8mm Implant Assembly, Sterile The Wenzel Spine primaLOK SP Interspinous Fusion System is a posterior, nonpedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). it is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), and/or tumor. The primaLOK SP Interspinous Fusion System is intended for use at one level with bone graft material and not intended for stand-alone use. | primaLOK SP | WENZEL SPINE, INC. | |
45 | 00813210021723 | 800-0106-00 | primaLOK SP 6mm Implant Assembly, Sterile primaLOK SP 6mm Implant Assembly, Sterile The Wenzel Spine primaLOK SP Interspinous Fusion System is a posterior, nonpedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). it is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), and/or tumor. The primaLOK SP Interspinous Fusion System is intended for use at one level with bone graft material and not intended for stand-alone use. | primaLOK SP | WENZEL SPINE, INC. | |
46 | 00813210021365 | 800-0501 | Auxiliary Instrument Case | primaLOK SP | WENZEL SPINE, INC. | |
47 | 00813210021358 | 800-0500 | Instrument Case | primaLOK SP | WENZEL SPINE, INC. | |
48 | 00812352021318 | 4302081 | Royal Oak Pedicle Screw Instrument Set Case 2 | Royal Oak Pedicle Screw System | ROYAL OAK MEDICAL DEVICES LLC | |
49 | 00812352021318 | 4302081 | Royal Oak Pedicle Screw Instrument Set Case 2 | Royal Oak Pedicle Screw System | ROYAL OAK MEDICAL DEVICES LLC | |
50 | 00812352021301 | 4301081 | Royal Oak Pedicle Screw Instrument Set Case 1 | Royal Oak Pedicle Screw System | ROYAL OAK MEDICAL DEVICES LLC |