No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 03663422604972 | 1 | 357CRC1 | Rod cutter | LXH | Orthopedic Manual Surgical Instrument | 1 | MONT BLANC |
2 | 03663422600110 | 1 | 008PRC1 | Ring curette, 5mm | LXH | Orthopedic Manual Surgical Instrument | 1 | TWIN PEAKS |
3 | 03663422051264 | 1 | TP1F14254 | Lumbar Cage Bullet Shaped H14/ L25/ 4° | MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | TWIN PEAKS |
4 | 03663422605696 | 1 | 426IFT1 | Final impactor, TLIF cage | LXH | Orthopedic Manual Surgical Instrument | 1 | TWIN PEAKS |
5 | 03663422605665 | 1 | 423HET1 | Extractor, TLIF cage | LXH | Orthopedic Manual Surgical Instrument | 1 | TWIN PEAKS |
6 | 03663422605641 | 1 | 421DL14R1 | Lumbar distractor, reamer, size 14mm | LXH | Orthopedic Manual Surgical Instrument | 1 | TWIN PEAKS |
7 | 03663422605634 | 1 | 420DL15T1 | Sizer, 15mm, TLIF | LXH | Orthopedic Manual Surgical Instrument | 1 | TWIN PEAKS |
8 | 03663422605627 | 1 | 419DL14T1 | Sizer, 14mm, TLIF | LXH | Orthopedic Manual Surgical Instrument | 1 | TWIN PEAKS |
9 | 03663422605405 | 1 | 397RD6A1 | Disc rongeur, upwards 45°, size 6 | LXH | Orthopedic Manual Surgical Instrument | 1 | TWIN PEAKS |
10 | 03663422605399 | 1 | 396PAL1 | Curette, reverse angle, left | LXH | Orthopedic Manual Surgical Instrument | 1 | TWIN PEAKS |
11 | 03663422605375 | 1 | 395IT1 | Impactor, TLIF cage | LXH | Orthopedic Manual Surgical Instrument | 1 | TWIN PEAKS |
12 | 03663422605368 | 1 | 394DLS1 | Lamina spreader | LXH | Orthopedic Manual Surgical Instrument | 1 | TWIN PEAKS |
13 | 03663422605351 | 1 | 393DL13R1 | Lumbar distractor, reamer, size 13mm | LXH | Orthopedic Manual Surgical Instrument | 1 | TWIN PEAKS |
14 | 03663422605344 | 1 | 392DL12R1 | Lumbar distractor, reamer, size 12mm | LXH | Orthopedic Manual Surgical Instrument | 1 | TWIN PEAKS |
15 | 03663422605337 | 1 | 391DL11R1 | Lumbar distractor, reamer, size 11mm | LXH | Orthopedic Manual Surgical Instrument | 1 | TWIN PEAKS |
16 | 03663422605320 | 1 | 390DL10R1 | Lumbar distractor, reamer, size 10mm | LXH | Orthopedic Manual Surgical Instrument | 1 | TWIN PEAKS |
17 | 03663422605313 | 1 | 389DL9R1 | Lumbar distractor, reamer, size 9mm | LXH | Orthopedic Manual Surgical Instrument | 1 | TWIN PEAKS |
18 | 03663422605306 | 1 | 388DL8R1 | Lumbar distractor, reamer, size 8mm | LXH | Orthopedic Manual Surgical Instrument | 1 | TWIN PEAKS |
19 | 03663422605290 | 1 | 387DL7R1 | Lumbar distractor, reamer, size 7mm | LXH | Orthopedic Manual Surgical Instrument | 1 | TWIN PEAKS |
20 | 03663422605276 | 1 | 386DL13T1 | Sizer, 13mm, TLIF | LXH | Orthopedic Manual Surgical Instrument | 1 | TWIN PEAKS |
21 | 03663422605269 | 1 | 385DL12T1 | Sizer, 12mm, TLIF | LXH | Orthopedic Manual Surgical Instrument | 1 | TWIN PEAKS |
22 | 03663422605252 | 1 | 384DL11T1 | Sizer, 11mm, TLIF | LXH | Orthopedic Manual Surgical Instrument | 1 | TWIN PEAKS |
23 | 03663422605245 | 1 | 383DL10T1 | Sizer, 10mm, TLIF | LXH | Orthopedic Manual Surgical Instrument | 1 | TWIN PEAKS |
24 | 03663422605238 | 1 | 382DL9T1 | Sizer, 9mm, TLIF | LXH | Orthopedic Manual Surgical Instrument | 1 | TWIN PEAKS |
25 | 03663422605221 | 1 | 381DL8T1 | Sizer, 8mm, TLIF | LXH | Orthopedic Manual Surgical Instrument | 1 | TWIN PEAKS |
26 | 03663422605214 | 1 | 380DL7T1 | Sizer, 7mm, TLIF | LXH | Orthopedic Manual Surgical Instrument | 1 | TWIN PEAKS |
27 | 03663422605207 | 1 | 379PAS1 | Curette, reverse angle, right | LXH | Orthopedic Manual Surgical Instrument | 1 | TWIN PEAKS |
28 | 03663422605191 | 1 | 378HLS1 | Impactor for lumbar cage bullet shaped, straight | LXH | Orthopedic Manual Surgical Instrument | 1 | TWIN PEAKS |
29 | 03663422605184 | 1 | 377DL7S1 | Lumbar distractor size 7mm | LXH | Orthopedic Manual Surgical Instrument | 1 | TWIN PEAKS |
30 | 03663422605177 | 1 | 376RL7S1 | Lumbar reamer size 7mm | LXH | Orthopedic Manual Surgical Instrument | 1 | TWIN PEAKS |
31 | 03663422604583 | 1 | 318HLP1 | Impactor for lumbar cage bullet shaped | LXH | Orthopedic Manual Surgical Instrument | 1 | TWIN PEAKS |
32 | 03663422603661 | 1 | 253RD3CL1 | Disc rongeur, curved, size 3, long | LXH | Orthopedic Manual Surgical Instrument | 1 | TWIN PEAKS |
33 | 03663422602725 | 1 | 196RD6CL1 | Disc rongeur, curved, size 6, long | LXH | Orthopedic Manual Surgical Instrument | 1 | TWIN PEAKS |
34 | 03663422602701 | 1 | 195RD6SL1 | Disc rongeur, straight, size 6, long | LXH | Orthopedic Manual Surgical Instrument | 1 | TWIN PEAKS |
35 | 03663422602688 | 1 | 194RD3SL1 | Disc rongeur, straight, size 3, long | LXH | Orthopedic Manual Surgical Instrument | 1 | TWIN PEAKS |
36 | 03663422601216 | 1 | 086ICW1 | Slap hammer | LXH | Orthopedic Manual Surgical Instrument | 1 | TWIN PEAKS |
37 | 03663422601155 | 1 | 079PRC1 | Ring curette, 9mm | LXH | Orthopedic Manual Surgical Instrument | 1 | TWIN PEAKS |
38 | 03663422601148 | 1 | 078PRC1 | Ring curette, 7mm | LXH | Orthopedic Manual Surgical Instrument | 1 | TWIN PEAKS |
39 | 03663422601124 | 2 | 076IGL2 | Graft pusher, lumbar cage | LXH | Orthopedic Manual Surgical Instrument | 1 | TWIN PEAKS |
40 | 03663422601063 | 3 | 072FL3 | Filling socket, lumbar cage | LXH | Orthopedic Manual Surgical Instrument | 1 | TWIN PEAKS |
41 | 03663422601018 | 1 | 070RL14L1 | Lumbar reamer size 14mm | LXH | Orthopedic Manual Surgical Instrument | 1 | TWIN PEAKS |
42 | 03663422601001 | 1 | 069RL13L1 | Lumbar reamer size 13mm | LXH | Orthopedic Manual Surgical Instrument | 1 | TWIN PEAKS |
43 | 03663422600998 | 1 | 068RL12M1 | Lumbar reamer size 12mm | LXH | Orthopedic Manual Surgical Instrument | 1 | TWIN PEAKS |
44 | 03663422600981 | 1 | 067RL11M1 | Lumbar reamer size 11mm | LXH | Orthopedic Manual Surgical Instrument | 1 | TWIN PEAKS |
45 | 03663422600974 | 1 | 066RL10S1 | Lumbar reamer size 10mm | LXH | Orthopedic Manual Surgical Instrument | 1 | TWIN PEAKS |
46 | 03663422600967 | 1 | 065RL9S1 | Lumbar reamer size 9mm | LXH | Orthopedic Manual Surgical Instrument | 1 | TWIN PEAKS |
47 | 03663422600950 | 1 | 064RL8S1 | Lumbar reamer size 8mm | LXH | Orthopedic Manual Surgical Instrument | 1 | TWIN PEAKS |
48 | 03663422600820 | 1 | 056DL14L1 | Lumbar distractor size 14mm | LXH | Orthopedic Manual Surgical Instrument | 1 | TWIN PEAKS |
49 | 03663422600806 | 1 | 055DL13L1 | Lumbar distractor size 13mm | LXH | Orthopedic Manual Surgical Instrument | 1 | TWIN PEAKS |
50 | 03663422600783 | 1 | 054DL12M1 | Lumbar distractor size 12mm | LXH | Orthopedic Manual Surgical Instrument | 1 | TWIN PEAKS |
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 |