| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 00822409114702 | C-1755-81 | Uni Femoral Drill-Thru Trial Size 8 Left | HSX | PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER | 2 | n/a | |
| 2 | 00822409114696 | C-1755-71 | Uni Femoral Drill-Thru Trial Size 7 Left | HSX | PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER | 2 | n/a | |
| 3 | 00822409114689 | C-1755-61 | Uni Femoral Drill-Thru Trial Size 6 Left | HSX | PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER | 2 | n/a | |
| 4 | 00822409114672 | C-1755-51 | Uni Femoral Drill-Thru Trial Size 5 Left | HSX | PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER | 2 | n/a | |
| 5 | 00822409114665 | C-1755-41 | Uni Femoral Drill-Thru Trial Size 4 Left | HSX | PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER | 2 | n/a | |
| 6 | 00822409114658 | C-1755-31 | Uni Femoral Drill-Thru Trial Size 3 Left | HSX | PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER | 2 | n/a | |
| 7 | 00822409114641 | C-1755-21 | Uni Femoral Drill-Thru Trial Size 2 Left | HSX | PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER | 2 | n/a | |
| 8 | 00822409114634 | C-1755-11 | Uni Femoral Drill-Thru Trial Size 1 Left | HSX | PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER | 2 | n/a | |
| 9 | 00822409114795 | C-1754 | Uni Drill-Thru Femoral Trial Lug Drill | HTW | BIT, DRILL | 1 | n/a | |
| 10 | 00822409114368 | C-1683 | Posterior Referencing Sizer with Adjustable Boom | LXH | Orthopedic manual surgical instrument | 1 | n/a | |
| 11 | 00822409114351 | C-1762-02 | Uni Tibial Cut Guide 3 Degree Right Uncaptured | LXH | Orthopedic manual surgical instrument | 1 | n/a | |
| 12 | 00822409114344 | C-1762-01 | Uni Tibial Cut Guide 3 Degree Left Uncaptured | LXH | Orthopedic manual surgical instrument | 1 | n/a | |
| 13 | 00822409114771 | C-1755-72 | Uni Femoral Drill-Thru Trial Size 7 Right | HSX | PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER | 2 | n/a | |
| 14 | 00822409114764 | C-1755-62 | Uni Femoral Drill-Thru Trial Size 6 Right | HSX | PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER | 2 | n/a | |
| 15 | 00822409114726 | C-1755-22 | Uni Femoral Drill-Thru Trial Size 2 Right | HSX | PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER | 2 | n/a | |
| 16 | 00822409114719 | C-1755-12 | Uni Femoral Drill-Thru Trial Size 1 Right | HSX | PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER | 2 | n/a | |
| 17 | 00822409114733 | C-1755-32 | Uni Femoral Drill-Thru Trial Size 3 Right | HSX | PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER | 2 | n/a | |
| 18 | 00822409114757 | C-1755-52 | Uni Femoral Drill-Thru Trial Size 5 Right | HSX | PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER | 2 | n/a | |
| 19 | 00822409114740 | C-1755-42 | Uni Femoral Drill-Thru Trial Size 4 Right | HSX | PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER | 2 | n/a | |
| 20 | 00822409114788 | C-1755-82 | Uni Femoral Drill-Thru Trial Size 8 Right | HSX | PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER | 2 | n/a | |
| 21 | 00822409114337 | C-1761-02 | Uni Tibial Cut Guide 3° Right Captured | LXH | Orthopedic manual surgical instrument | 1 | n/a | |
| 22 | 00822409114320 | C-1761-01 | Uni Tibial Cut Guide 3° Left Captured | LXH | Orthopedic manual surgical instrument | 1 | n/a | |
| 23 | 00822409114245 | C-1752-03 | Uni Shim, 3 mm | LXH | Orthopedic manual surgical instrument | 1 | n/a | |
| 24 | 00822409114238 | C-1752-02 | Uni Shim, 2 mm | LXH | Orthopedic manual surgical instrument | 1 | n/a | |
| 25 | 00822409114207 | C-1760 | Uni Alignment Rod Adapter | LXH | Orthopedic manual surgical instrument | 1 | n/a | |
| 26 | 00822409114191 | C-1759-15 | Uni Spacer Block 15mm x 22mm | LXH | Orthopedic manual surgical instrument | 1 | n/a | |
| 27 | 00822409114184 | C-1759-14 | Uni Spacer Block 14mm x 21mm | LXH | Orthopedic manual surgical instrument | 1 | n/a | |
| 28 | 00822409114177 | C-1759-13 | Uni Spacer Block 13mm x 20mm | LXH | Orthopedic manual surgical instrument | 1 | n/a | |
| 29 | 00822409114160 | C-1759-12 | Uni Spacer Block 12mm x 19mm | LXH | Orthopedic manual surgical instrument | 1 | n/a | |
| 30 | 00822409114153 | C-1759-11 | Uni Spacer Block 11mm x 18mm | LXH | Orthopedic manual surgical instrument | 1 | n/a | |
| 31 | 00822409114146 | C-1759-10 | Uni Spacer Block 10mm x 17mm | LXH | Orthopedic manual surgical instrument | 1 | n/a | |
| 32 | 00822409114139 | C-1759-09 | Uni Spacer Block 9mm x 16mm | LXH | Orthopedic manual surgical instrument | 1 | n/a | |
| 33 | 00822409114122 | C-1759-08 | Uni Spacer Block 8mm x 15mm | LXH | Orthopedic manual surgical instrument | 1 | n/a | |
| 34 | 00822409114115 | C-1756 | Slim I/M Sleeve Adapter | LXH | Orthopedic Manual Surgical Instrument | 1 | n/a | |
| 35 | 00822409114108 | C-1749-52 | Uni Femoral Monoblock Distal Cut Guide R 13 x 5 | LXH | Orthopedic manual surgical instrument | 1 | n/a | |
| 36 | 00822409114092 | C-1749-42 | Uni Femoral Monoblock Distal Cut Guide R 12 x 5 | LXH | Orthopedic manual surgical instrument | 1 | n/a | |
| 37 | 00822409114085 | C-1749-32 | Uni Femoral Monoblock Distal Cut Guide R 11 x 6 | LXH | Orthopedic manual surgical instrument | 1 | n/a | |
| 38 | 00822409114078 | C-1749-22 | Uni Femoral Monoblock Distal Cut Guide R 10 x 7 | LXH | Orthopedic manual surgical instrument | 1 | n/a | |
| 39 | 00822409114061 | C-1749-12 | Uni Femoral Monoblock Distal Cut Guide R 9 x 8 | LXH | Orthopedic manual surgical instrument | 1 | n/a | |
| 40 | 00822409114054 | C-1749-02 | Uni Femoral Monoblock Distal Cut Guide R 9 x 7 | LXH | Orthopedic manual surgical instrument | 1 | n/a | |
| 41 | 00822409114047 | C-1749-51 | Uni Femoral Monoblock Distal Cut Guide L 13 x 5 | LXH | Orthopedic manual surgical instrument | 1 | n/a | |
| 42 | 00822409114030 | C-1749-41 | Uni Femoral Monoblock Distal Cut Guide L 12 x 5 | LXH | Orthopedic manual surgical instrument | 1 | n/a | |
| 43 | 00822409110940 | C-1645 | Ratcheting Handle | LXH | Orthopedic manual surgical instrument | 1 | n/a | |
| 44 | 00822409114023 | C-1749-31 | Uni Femoral Monoblock Distal Cut Guide L 11 x 6 | LXH | Orthopedic manual surgical instrument | 1 | n/a | |
| 45 | 00822409114016 | C-1749-21 | Uni Femoral Monoblock Distal Cut Guide L 10 x 7 | LXH | Orthopedic manual surgical instrument | 1 | n/a | |
| 46 | 00822409114009 | C-1749-11 | Uni Femoral Monoblock Distal Cut Guide L 9 x 8 | LXH | Orthopedic manual surgical instrument | 1 | n/a | |
| 47 | 00822409113996 | C-1749-01 | Uni Femoral Monoblock Distal Cut Guide L 9 x 7 | LXH | Orthopedic manual surgical instrument | 1 | n/a | |
| 48 | 00822409113989 | C-1751 | Uni Stabilizer Block Curved 9mm | LXH | Orthopedic manual surgical instrument | 1 | n/a | |
| 49 | 00822409113972 | C-1750 | Uni Stabilizer Block Flat 9mm | LXH | Orthopedic manual surgical instrument | 1 | n/a | |
| 50 | 00822409113965 | C-1344-38 | A/P Sizing Guide Left Paddle | LXH | Orthopedic manual surgical instrument | 1 | n/a |
| 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 |