No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 18257200015986 | 52-2060 | 60mm Rod | NKB | Orthosis, spinal pedicle fixation, for degenerative disc disease | 2 | FIREBIRD | |
2 | 18257200142163 | 28-1124 | FUNNEL PLUNGER | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | FORZA XP | |
3 | 18257200125357 | 79-1012 | BONE CHISEL | FZO | CHISEL, SURGICAL, MANUAL | 1 | CONNECTOR | |
4 | 18257200063215 | 65-1048 | COMPRESSOR, ASCENT POCT | HWN | INSTRUMENT, COMPRESSION | 1 | ASCENT | |
5 | 18257200053797 | 55-1049 | ROD PUSHER | HXO | PUSHER, SOCKET | 1 | SFS | |
6 | 18257200042401 | 48-1003 | PILLAR AL BONE PACKER | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | CONSTRUX - PEEK VBR;PILLAR AL | |
7 | 18257200031689 | 40-0001 | Small Plate | NQW | Orthosis, Spine, Plate, Laminoplasty, Metal | 2 | NEWBRIDGE | |
8 | 18257200018567 | 65-2070 | 70MM ROD, ASCENT LE/ASCENT POCT | KWP | APPLIANCE, FIXATION, SPINAL INTERLAMINAL | 2 | ASCENT | |
9 | 18257200099702 | 27-3617 | 22W X 60L X 0 DEG X 17H IMPLANT | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | SKYHAWK | |
10 | 18257200110629 | 450427-0003 | 27-9091 | SKYHAWK - INTERBODY INSTRUMENT TRAY KIT | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | SKYHAWK |
11 | 18257200108909 | 24-1092 | FINAL TIGHTENING DRIVER | HWR | DRIVER, PROSTHESIS | 1 | SKYHAWK | |
12 | 18257200108893 | 24-1065 | 5.5MM DRILL | HTW | BIT, DRILL | 1 | SKYHAWK | |
13 | 18257200108886 | 24-1062 | AWL | HWJ | AWL | 1 | SKYHAWK | |
14 | 18257200108879 | 24-1061 | AWL SLEEVE | HWJ | AWL | 1 | SKYHAWK | |
15 | 18257200108862 | 24-1050 | RONGEUR, BONE BITING | HTX | RONGEUR | 1 | SKYHAWK | |
16 | 18257200108855 | 24-1001 | MODULAR IN-LINE HANDLE | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | SKYHAWK | |
17 | 18257200106011 | 83-9043 | WEDGE DISTRACTOR | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | LONESTAR | |
18 | 18257200106004 | 83-9040 | UNIVERSAL RASP | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | LONESTAR | |
19 | 18257200105991 | 83-9038 | MALLET | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | LONESTAR | |
20 | 18257200105984 | 83-9037 | GRAFT TAMP | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | LONESTAR | |
21 | 18257200105977 | 83-9030 | GRAFT BLOCK | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | LONESTAR | |
22 | 18257200105564 | 71-5015 | K-WIRE | GAD | RETRACTOR | 1 | SKYHAWK | |
23 | 18257200103089 | 27-5520 | 22W X 60L X 8 DEGREE X 20H TRIAL | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | SKYHAWK | |
24 | 18257200103072 | 27-5519 | 22W X 60L X 8 DEGREE X 19H TRIAL | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | SKYHAWK | |
25 | 18257200103065 | 27-5518 | 22W X 60L X 8 DEGREE X 18H TRIAL | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | SKYHAWK | |
26 | 18257200103058 | 27-5517 | 22W X 60L X 8 DEGREE X 17H TRIAL | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | SKYHAWK | |
27 | 18257200103041 | 27-5516 | 22W X 60L X 8 DEGREE X 16H TRIAL | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | SKYHAWK | |
28 | 18257200103034 | 27-5515 | 22W X 60L X 8 DEGREE X 15H TRIAL | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | SKYHAWK | |
29 | 18257200103027 | 27-5514 | 22W X 60L X 8 DEGREE X 14H TRIAL | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | SKYHAWK | |
30 | 18257200103010 | 27-5513 | 22W X 60L X 8 DEGREE X 13H TRIAL | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | SKYHAWK | |
31 | 18257200103003 | 27-5512 | 22W X 60L X 8 DEGREE X 12H TRIAL | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | SKYHAWK | |
32 | 18257200102990 | 27-5511 | 22W X 60L X 8 DEGREE X 11H TRIAL | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | SKYHAWK | |
33 | 18257200102983 | 27-5510 | 22W X 60L X 8 DEGREE X 10H TRIAL | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | SKYHAWK | |
34 | 18257200102976 | 27-5509 | 22W X 60L X 8 DEGREE X 9H TRIAL | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | SKYHAWK | |
35 | 18257200102969 | 27-5508 | 22W X 60L X 8 DEGREE X 8H TRIAL | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | SKYHAWK | |
36 | 18257200102952 | 27-5420 | 18W X 60L X 8 DEGREE X 20H TRIAL | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | SKYHAWK | |
37 | 18257200102945 | 27-5419 | 18W X 60L X 8 DEGREE X 19H TRIAL | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | SKYHAWK | |
38 | 18257200102938 | 27-5418 | 18W X 60L X 8 DEGREE X 18H TRIAL | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | SKYHAWK | |
39 | 18257200102921 | 27-5417 | 18W X 60L X 8 DEGREE X 17H TRIAL | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | SKYHAWK | |
40 | 18257200102914 | 27-5416 | 18W X 60L X 8 DEGREE X 16H TRIAL | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | SKYHAWK | |
41 | 18257200102907 | 27-5415 | 18W X 60L X 8 DEGREE X 15H TRIAL | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | SKYHAWK | |
42 | 18257200102891 | 27-5414 | 18W X 60L X 8 DEGREE X 14H TRIAL | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | SKYHAWK | |
43 | 18257200102884 | 27-5413 | 18W X 60L X 8 DEGREE X 13H TRIAL | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | SKYHAWK | |
44 | 18257200102877 | 27-5412 | 18W X 60L X 8 DEGREE X 12H TRIAL | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | SKYHAWK | |
45 | 18257200102860 | 27-5411 | 18W X 60L X 8 DEGREE X 11H TRIAL | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | SKYHAWK | |
46 | 18257200102853 | 27-5410 | 18W X 60L X 8 DEGREE X 10H TRIAL | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | SKYHAWK | |
47 | 18257200102846 | 27-5409 | 18W X 60L X 8 DEGREE X 9H TRIAL | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | SKYHAWK | |
48 | 18257200102839 | 27-5408 | 18W X 60L X 8 DEGREE X 8H TRIAL | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | SKYHAWK | |
49 | 18257200102822 | 27-5320 | 22W X 60L X 0 DEGREE X 20H TRIAL | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | SKYHAWK | |
50 | 18257200102815 | 27-5319 | 22W X 60L X 0 DEGREE X 19H TRIAL | LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 1 | SKYHAWK |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | M9935023141 | 502314 | Spacer | GSO GS1 Spacer | GOLD STANDARD ORTHOPEDICS, LLC | |
2 | M9935023140 | 502314 | Spacer | GSO GS1 Spacer | GOLD STANDARD ORTHOPEDICS, LLC | |
3 | M9935023131 | 502313 | Spacer | GSO GS1 Spacer | GOLD STANDARD ORTHOPEDICS, LLC | |
4 | M9935023130 | 502313 | Spacer | GSO GS1 Spacer | GOLD STANDARD ORTHOPEDICS, LLC | |
5 | M9935023121 | 502312 | Spacer | GSO GS1 Spacer | GOLD STANDARD ORTHOPEDICS, LLC | |
6 | M9935023120 | 502312 | Spacer | GSO GS1 Spacer | GOLD STANDARD ORTHOPEDICS, LLC | |
7 | M9935023111 | 502311 | Spacer | GSO GS1 Spacer | GOLD STANDARD ORTHOPEDICS, LLC | |
8 | M9935023110 | 502311 | Spacer | GSO GS1 Spacer | GOLD STANDARD ORTHOPEDICS, LLC | |
9 | M9935023101 | 502310 | Spacer | GSO GS1 Spacer | GOLD STANDARD ORTHOPEDICS, LLC | |
10 | M9935023100 | 502310 | Spacer | GSO GS1 Spacer | GOLD STANDARD ORTHOPEDICS, LLC | |
11 | M9935023091 | 502309 | Spacer | GSO GS1 Spacer | GOLD STANDARD ORTHOPEDICS, LLC | |
12 | M9935023090 | 502309 | Spacer | GSO GS1 Spacer | GOLD STANDARD ORTHOPEDICS, LLC | |
13 | M9935023081 | 502308 | Spacer | GSO GS1 Spacer | GOLD STANDARD ORTHOPEDICS, LLC | |
14 | M9935023080 | 502308 | Spacerhttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=man Spacerhttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=71318# | GSO GS1 Spacer | GOLD STANDARD ORTHOPEDICS, LLC | |
15 | M9935023071 | 502307 | Spacer | GSO GS1 Spacer | GOLD STANDARD ORTHOPEDICS, LLC | |
16 | M9935023070 | 502307 | Spacer | GSO GS1 Spacer | GOLD STANDARD ORTHOPEDICS, LLC | |
17 | 20721902068342 | 8914000 | M4 BREAK-OFF SCREW | VERTE-SPAN® Spinal System | MEDTRONIC SOFAMOR DANEK, INC. | |
18 | 20705034755516 | 08.807.300.02S | 0880730002S | XRL LARGE ENDPLATE SCREWS- STERILE | XRL | SYNTHES GMBH |
19 | 20705034755196 | 08.807.200.02S | 0880720002S | XRL MEDIUM ENDPLATE SCREWS- STERILE | XRL | SYNTHES GMBH |
20 | 20673978081148 | 905-800 | MESH 905-800 PYRM END RING SET SCRW | PYRAMESH® C Titanium Mesh | MEDTRONIC SOFAMOR DANEK, INC. | |
21 | 18257200081707 | 450259-0001 | 74-0005 | NGAGE IMPLANT (74-0005) | NGAGE | ORTHOFIX INC. |
22 | 18257200081691 | 450258-0001 | 74-0006 | NGAGE INST (74-0006) | NGAGE | ORTHOFIX INC. |
23 | 18257200081394 | 450218-0001 | 48-0020 | PILLAR AL INST (48-0020) | CONSTRUX - PEEK VBR;PILLAR AL | ORTHOFIX INC. |
24 | 18257200081387 | 450217-0001 | 48-0010 | PILLAR AL (48-0010) | CONSTRUX - PEEK VBR | ORTHOFIX INC. |
25 | 18257200081318 | 450211-0001 | 45-0051 | PILLAR TL PEEK PARTIAL VBR SYSTEM, IMPLANT/INSTRUMENT CASE (45-0051) | PILLAR TL | ORTHOFIX INC. |
26 | 18257200081295 | 450209-0001 | 46-0020 | PILLAR PL/TL VBR SYSTEM, 11MM X 33MM IMPLANTS AND TRIALS (46-0020) | PILLAR TL | ORTHOFIX INC. |
27 | 18257200081271 | 450207-0001 | 45-9098 | PILLAR TL (45-9098) | PILLAR TL | ORTHOFIX INC. |
28 | 18257200081257 | 450205-0001 | 45-0011 | CONSTRUX PEEK VBR SYSTEM, IMPLANT AND INSTRUMENT CASE (45-0011) | CONSTRUX - PEEK VBR | ORTHOFIX INC. |
29 | 18257200081240 | 450204-0001 | 45-0020 | CONSTRUX PEEK VBR SYSTEM, INSTRUMENT CASE 2 (45-0020) | CONSTRUX - PEEK VBR | ORTHOFIX INC. |
30 | 18257200081233 | 450203-0001 | 45-0010 | CONSTRUX PEEK VBR IMPLANT SYSTEM - CASE 1 (45-0010) | CONSTRUX - PEEK VBR | ORTHOFIX INC. |
31 | 18257200074419 | 76-7026 | NGAGE 6-LOBE 26X33MM STANDARD RING | NGAGE | ORTHOFIX INC. | |
32 | 18257200074402 | 76-7022 | NGAGE 6-LOBE 22X28MM STANDARD RING | NGAGE | ORTHOFIX INC. | |
33 | 18257200074396 | 76-7017 | NGAGE 6-LOBE 17X22MM STANDARD RING | NGAGE | ORTHOFIX INC. | |
34 | 18257200074389 | 76-7013 | NGAGE 6-LOBE 13X17MM STANDARD RING | NGAGE | ORTHOFIX INC. | |
35 | 18257200074372 | 76-7012 | NGAGE 6-LOBE 12X15MM STANDARD RING | NGAGE | ORTHOFIX INC. | |
36 | 18257200074365 | 76-7001 | NGAGE 6-LOBE SCREW STANDARD RING | NGAGE | ORTHOFIX INC. | |
37 | 18257200074358 | 76-6026 | NGAGE 6-LOBE 5DEG ANGLED END CAP, 26MM | NGAGE | ORTHOFIX INC. | |
38 | 18257200074341 | 76-6022 | NGAGE 6-LOBE 5DEG ANGLED END CAP, 22MM | NGAGE | ORTHOFIX INC. | |
39 | 18257200074334 | 76-6017 | NGAGE 6-LOBE 5DEG ANGLED END CAP, 17MM | NGAGE | ORTHOFIX INC. | |
40 | 18257200074327 | 76-6013 | NGAGE 6-LOBE 5DEG ANGLED END CAP, 13MM | NGAGE | ORTHOFIX INC. | |
41 | 18257200074310 | 76-6012 | NGAGE 6-LOBE 5DEG ANGLED END CAP, 12MM | NGAGE | ORTHOFIX INC. | |
42 | 18257200074303 | 76-5026 | NGAGE 6-LOBE PARALLEL END CAP, 26MM | NGAGE | ORTHOFIX INC. | |
43 | 18257200074297 | 76-5022 | NGAGE 6-LOBE PARALLEL END CAP, 22MM | NGAGE | ORTHOFIX INC. | |
44 | 18257200074280 | 76-5017 | NGAGE 6-LOBE PARALLEL END CAP, 17MM | NGAGE | ORTHOFIX INC. | |
45 | 18257200074273 | 76-5013 | NGAGE 6-LOBE PARALLEL END CAP, 13MM | NGAGE | ORTHOFIX INC. | |
46 | 18257200074266 | 76-5012 | NGAGE 6-LOBE PARALLEL END CAP, 12MM | NGAGE | ORTHOFIX INC. | |
47 | 18257200074259 | 76-2690 | NGAGE 6-LOBE 26X33MM MESH, 90MM | NGAGE | ORTHOFIX INC. | |
48 | 18257200074242 | 76-2680 | NGAGE 6-LOBE 26X33MM, 80MM HEIGHT | NGAGE | ORTHOFIX INC. | |
49 | 18257200074235 | 76-2670 | NGAGE 6-LOBE 26X33MM MESH, 70MM | NGAGE | ORTHOFIX INC. | |
50 | 18257200074228 | 76-2660 | NGAGE 6-LOBE 26X33MM, 60MM HEIGHT | NGAGE | ORTHOFIX INC. |