No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00810045536187 | ASY-00983 | ASY-00983 | Le Rasp | LXH | Orthopedic Manual Surgical Instrument | 1 | N/A |
2 | 00840200409100 | CMP-02563 | CMP-02563 | Distractor 11mm - 13mm | LXH | Orthopedic Manual Surgical Instrument | 1 | N/A |
3 | 00840200408929 | CMP-02562 | CMP-02562 | Distractor 9mm - 11mm | LXH | Orthopedic Manual Surgical Instrument | 1 | N/A |
4 | 00850231007145 | II-1-0144 | II-1-0144 | Instrument Case | FSM | Tray, Surgical, Instrument | 1 | NA |
5 | 00840200408912 | CMP-02561 | CMP-02561 | Distractor 7mm - 9mm | LXH | Orthopedic Manual Surgical Instrument | 1 | N/A |
6 | 00850231007923 | II-1-0312 | II-1-0312 | 10mm Paddle Distractor | LXH | Orthopedic Manual Surgical Instrument | 1 | NA |
7 | 00850231007992 | II-1-0319 | II-1-0319 | 8mm Shaver | LXH | Orthopedic Manual Surgical Instrument | 1 | NA |
8 | 00850231007985 | II-1-0318 | II-1-0318 | 7mm Shaver | LXH | Orthopedic Manual Surgical Instrument | 1 | NA |
9 | 00850231007961 | II-1-0316 | II-1-0316 | 14mm Paddle Distractor | LXH | Orthopedic Manual Surgical Instrument | 1 | NA |
10 | 00850231007954 | II-1-0315 | II-1-0315 | 13mm Paddle Distractor | LXH | Orthopedic Manual Surgical Instrument | 1 | NA |
11 | 00850231007947 | II-1-0314 | II-1-0314 | 12mm Paddle Distractor | LXH | Orthopedic Manual Surgical Instrument | 1 | NA |
12 | 00850231007930 | II-1-0313 | II-1-0313 | 11mm Paddle Distractor | LXH | Orthopedic Manual Surgical Instrument | 1 | NA |
13 | 00850231007916 | II-1-0311 | II-1-0311 | 9mm Paddle Distractor | LXH | Orthopedic Manual Surgical Instrument | 1 | NA |
14 | 00850231007909 | II-1-0310 | II-1-0310 | 8mm Paddle Distractor | LXH | Orthopedic Manual Surgical Instrument | 1 | NA |
15 | 00850231007893 | II-1-0309 | II-1-0309 | 7mm Paddle Distractor | LXH | Orthopedic Manual Surgical Instrument | 1 | NA |
16 | 00850231007763 | II-1-0245 | II-1-0245 | Cup Curette - 4mm x 8mm Oval - Straight | LXH | Orthopedic Manual Surgical Instrument | 1 | NA |
17 | 00850231007725 | II-1-0240 | II-1-0240 | 8mm Round - Angled 15 degrees | LXH | Orthopedic Manual Surgical Instrument | 1 | NA |
18 | 00850231007329 | II-1-0005 | II-1-0005 | Slap Hammer | LXH | Orthopedic Manual Surgical Instrument | 1 | NA |
19 | 00850231007305 | II-1-0045 | II-1-0045 | Impact Cap | LXH | Orthopedic Manual Surgical Instrument | 1 | NA |
20 | 00850231007299 | II-1-0097 | II-1-0097 | Shim Retractor | LXH | Orthopedic Manual Surgical Instrument | 1 | NA |
21 | 00850231007282 | II-1-0276 | II-1-0276 | Shell Retriever | LXH | Orthopedic Manual Surgical Instrument | 1 | NA |
22 | 00850231007275 | II-1-0042 | II-1-0042 | Bone Tamp | LXH | Orthopedic Manual Surgical Instrument | 1 | NA |
23 | 00850231007268 | II-1-0038 | II-1-0038 | Bone Funnel | LXH | Orthopedic Manual Surgical Instrument | 1 | NA |
24 | 00850231007251 | II-1-0037 | II-1-0037 | Torque Limiting Axial Handle 12 in-lb | LXH | Orthopedic Manual Surgical Instrument | 1 | N/A |
25 | 00850231007244 | II-1-0036 | II-1-0036 | Torque Limiting T-Handle 28 in-lb | LXH | Orthopedic Manual Surgical Instrument | 1 | N/A |
26 | 00850231007190 | II-1-0001 | II-1-0001 | 8mm Paddle Distractor | LXH | Orthopedic Manual Surgical Instrument | 1 | N/A |
27 | 00850231007183 | II-1-0035 | II-1-0035 | 14mm Shaver | LXH | Orthopedic Manual Surgical Instrument | 1 | N/A |
28 | 00850231007176 | II-1-0034 | II-1-0034 | 12mm Shaver | LXH | Orthopedic Manual Surgical Instrument | 1 | NA |
29 | 00850231007169 | II-1-0031 | II-1-0031 | 6mm Shaver | LXH | Orthopedic Manual Surgical Instrument | 1 | N/A |
30 | 00850231007152 | II-1-0015 | II-1-0015 | Guide Pin Wrench | LXH | Orthopedic Manual Surgical Instrument | 1 | N/A |
31 | 00850231007121 | II-1-0145 | II-1-0145 | FH Implant Case | FSM | Tray, Surgical, Instrument | 1 | N/A |
32 | 00850231007015 | II-1-0032 | II-1-0032 | 8mm Shaver | LXH | Orthopedic Manual Surgical Instrument | 1 | NA |
33 | 00850231007008 | II-1-0033 | II-1-0033 | 10mm Shaver | LXH | Orthopedic Manual Surgical Instrument | 1 | NA |
34 | 00840200409322 | ASY-01087 | ASY-01087 | Tab Grabber | LXH | Orthopedic Manual Surgical Instrument | 1 | NA |
35 | 00840200409247 | CMP-02593 | CMP-02593 | DISTRACTOR 6mm-7mm | LXH | Orthopedic Manual Surgical Instrument | 1 | NA |
36 | 00840200409179 | CMP-02584 | CMP-02584 | O'Shaughnessy Tapered Set Screw Driver | HXX | Screwdriver | 1 | NA |
37 | 00840200408844 | ASY-01044 | ASY-01044 | O'Shaughnessy Tapered Set Screw Driver | HXX | Screwdriver | 1 | NA |
38 | 00840200408783 | ASY-01041 | ASY-01041 | 6mm Pituitary | HTX | Rongeur | 1 | NA |
39 | 00840200408776 | ASY-01040 | ASY-01040 | 6mm Kerrison | HTX | Rongeur | 1 | NA |
40 | 00840200408769 | ASY-01039 | ASY-01039 | Extra Large Curette | LXH | Orthopedic Manual Surgical Instrument | 1 | NA |
41 | 00840200408752 | ASY-01038 | ASY-01038 | Extra Large Up Curette | LXH | Orthopedic Manual Surgical Instrument | 1 | NA |
42 | 00840200408738 | ASY-01036 | ASY-01036 | Large Leksell | HTX | Rongeur | 1 | NA |
43 | 00840200408721 | ASY-01035 | ASY-01035 | Medium Leksell | HTX | Rongeur | 1 | NA |
44 | 00840200408714 | ASY-01034 | ASY-01034 | Narrow Rasp | LXH | Orthopedic Manual Surgical Instrument | 1 | N/A |
45 | 00840200408707 | ASY-01033 | ASY-01033 | 24mm 10° Angled Cobb | LXH | Orthopedic Manual Surgical Instrument | 1 | NA |
46 | 00840200408691 | ASY-01032 | ASY-01032 | 24mm Straight Cobb | LXH | Orthopedic Manual Surgical Instrument | 1 | NA |
47 | 00840200408677 | ASY-01031 | ASY-01031 | MIS Disc Prep Top Tray Insert | FSM | Tray, Surgical, Instrument | 1 | NA |
48 | 00840200408660 | ASY-01030 | ASY-01030 | MIS Disc Prep Middle Tray Insert | FSM | Tray, Surgical, Instrument | 1 | NA |
49 | 00840200408653 | ASY-01029 | ASY-01029 | MIS Disc Prep Bottom Tray Insert | FSM | Tray, Surgical, Instrument | 1 | NA |
50 | 00840200408646 | ASY-01028 | ASY-01028 | MIS Disc Prep Base | FSM | Tray, Surgical, Instrument | 1 | NA |
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 |