| Primary Device ID | 00810022402108 |
| NIH Device Record Key | eebae1e2-74f6-431d-90ee-b2bcb0a5e7e6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | LinkBio Instrument |
| Version Model Number | 87-1901/04 |
| Catalog Number | 87-1901/04 |
| Company DUNS | 827608774 |
| Company Name | Link Bio Corp |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810022402108 [Primary] |
| HTQ | Broach |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00810022402108]
Moist Heat or Steam Sterilization
[00810022402108]
Moist Heat or Steam Sterilization
[00810022402108]
Moist Heat or Steam Sterilization
[00810022402108]
Moist Heat or Steam Sterilization
[00810022402108]
Moist Heat or Steam Sterilization
[00810022402108]
Moist Heat or Steam Sterilization
[00810022402108]
Moist Heat or Steam Sterilization
[00810022402108]
Moist Heat or Steam Sterilization
[00810022402108]
Moist Heat or Steam Sterilization
[00810022402108]
Moist Heat or Steam Sterilization
[00810022402108]
Moist Heat or Steam Sterilization
[00810022402108]
Moist Heat or Steam Sterilization
[00810022402108]
Moist Heat or Steam Sterilization
[00810022402108]
Moist Heat or Steam Sterilization
[00810022402108]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-06-11 |
| Device Publish Date | 2021-06-03 |
| 00810022402351 | LinkBio Instruments Tray: TrabecuLink Tibial Cones |
| 00810022401590 | LinkBio Instrument Tray (Mega C): Mega C General Instruments |
| 00810022401583 | LinkBio Instrument Trays (Mega C): Mega C Assembly Tools |
| 00810022401576 | LinkBio Instrument Tray (Mega C): Mega C Proximal Femur General Instruments |
| 00810022401569 | LinkBio Instruments Tray (Mega C): Mega C Stem Segments/Push Thru/Intercalary Trials |
| 00810022401552 | LinkBio Instrument Tray (Mega C): Mega C SL Tibia Prep Instruments |
| 00810022401545 | LinkBio Instrument Tray (Mega C): Mega C General Tibia Stem Trials and Extraction Tools |
| 00810022401538 | LinkBio Instrument Tray (Mega C): Mega C SL Femoral, Tibia Trials & Augments |
| 00810022401521 | LinkBio Instrument Trays (Mega C): Mega C Classic Femoral & Tibia Augments and Trials |
| 00810022401514 | LinkBio Instrument Tray (Mega C): Mega C Classic Femoral & Tibia Prep Inst. With Trials |
| 00810022401507 | LinkBio Instrument Trays (Mega C): Mega C 160mm Reamers and 160mm Femoral Stem Trials |
| 00810022401491 | LinkBio Instrument Trays (Mega C): Mega C 130mm Reamers and 130mm Femoral Stem Trials |
| 00810022401484 | LinkBio Instrument Tray (Mega C): Mega C 100mm Reamers and 100mm Femoral Stem Trials |
| 00810022402344 | Guide Rod, Tibial Cone, D 16/180 L |
| 00810022402337 | Guide Rod, Tibial Cone, D 14/180 L |
| 00810022402320 | Guide Rod, Tibial Cone, D 12/180 L |
| 00810022402313 | Guide Rod, Tibial Cone, D 10/180 L |
| 00810022402306 | Guide Rod, Tibial Cone, D 8/180 L |
| 00810022402290 | Broach, Tibial Cone, Starter Full |
| 00810022402283 | Broach, Tibial Cone, Starter Half |
| 00810022402276 | Guide Rod, Tibial Cone, D 18/120 L |
| 00810022402269 | Guide Rod, Tibial Cone, D 16/120 L |
| 00810022402252 | Guide Rod, Tibial Cone, D 14/120 L |
| 00810022402245 | Guide Rod, Tibial Cone, D 12/120 L |
| 00810022402238 | Guide Rod, Tibial Cone, D 10/120 L |
| 00810022402207 | Starter Reamer, Tibial Cone |
| 00810022402146 | Broach, Tibial Cone, L Full |
| 00810022402139 | Broach, Tibial Cone, M Full |
| 00810022402122 | Broach, Tibial Cone, S Full |
| 00810022402115 | Broach, Tibial Cone, XS Full |
| 00810022402108 | Broach, Tibial Cone, L Half |
| 00810022402092 | Broach, Tibial Cone, M Half |
| 00810022402085 | Broach, Tibial Cone, S Half |
| 00810022402078 | Broach, Tibial Cone, XS Half |
| 00810022400005 | SL Valgus Block with Drill Holes |
| 00810022402573 | Starter Reamer, Cone |
| 00810022401897 | Endo W/M Tibial Trial, Modular Post - Large |
| 00810022401880 | Endo W/M Tibial Trial, Modular Post - Medium |
| 00810022401873 | Endo W/M Tibial Trial, Modular Post - Small |
| 00810022401866 | Endo W Femoral Trial Adaptor - Modular Post |
| 00810022401859 | Endo M/W Femoral Trial, Modular Post - Large, Right |
| 00810022401842 | Endo M/W Femoral Trial, Modular Post - Large, Left |
| 00810022401835 | Endo M/W Femoral Trial, Modular Post - Medium, Right |
| 00810022401828 | Endo M/W Femoral Trial, Modular Post - Medium, Left |
| 00810022401811 | Endo M/W Femoral Trial, Modular Post - Small, Right |
| 00810022401804 | Endo M/W Femoral Trial, Modular Post - Small, Left |
| 00810022403013 | Impactor Plate, Tibial Cone Large |
| 00810022403006 | Impactor Plate, Tibial Cone Medium |
| 00810022402993 | Impactor Plate, Tibial Cone Small |
| 00810022402986 | Impactor Plate, Tibial Cone Extra Small |