| Primary Device ID | 08806189871361 |
| NIH Device Record Key | c28332fa-8929-431e-bc3b-f56e46f0aa96 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | LnK MIS Spinal System |
| Version Model Number | 2510-55120 |
| Catalog Number | 2510-55120 |
| Company DUNS | 631159324 |
| Company Name | L&K BIOMED CO. ,LTD. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08806189871361 [Primary] |
| MNI | Orthosis, Spinal Pedicle Fixation |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08806189871361]
Moist Heat or Steam Sterilization
[08806189871361]
Moist Heat or Steam Sterilization
[08806189871361]
Moist Heat or Steam Sterilization
[08806189871361]
Moist Heat or Steam Sterilization
[08806189871361]
Moist Heat or Steam Sterilization
[08806189871361]
Moist Heat or Steam Sterilization
[08806189871361]
Moist Heat or Steam Sterilization
[08806189871361]
Moist Heat or Steam Sterilization
[08806189871361]
Moist Heat or Steam Sterilization
[08806189871361]
Moist Heat or Steam Sterilization
[08806189871361]
Moist Heat or Steam Sterilization
[08806189871361]
Moist Heat or Steam Sterilization
[08806189871361]
Moist Heat or Steam Sterilization
[08806189871361]
Moist Heat or Steam Sterilization
[08806189871361]
Moist Heat or Steam Sterilization
[08806189871361]
Moist Heat or Steam Sterilization
[08806189871361]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2024-05-28 |
| Device Publish Date | 2015-05-18 |
| 08806189872108 | L&K Biomed MIS Rod, Cuved 5.5x80mm 1EA |
| 08806189871507 | L&K Biomed MIS Rod, Straight 5.5x260mm 1EA |
| 08806189871361 | L&K Biomed MIS Rod, Straight 5.5x120mm 1EA |
| 08806189871255 | L&K Biomed MIS Rod, Straight 5.5x55mm 1EA |
| 08806189871200 | L&K Biomed MIS Poly Axial Screw, Open 7.5x60mm 1EA |
| 08806189870838 | L&K Biomed MIS Poly Axial Screw, Open 5.5x50mm 1EA |
| 08806189870333 | L&K Biomed MIS Poly Axial Screw, Open 7.5x45mm 1EA |
| 08806189869719 | L&K Biomed MIS Poly Axial Screw, Open 7.5x50mm 1EA |
| 08806189869627 | L&K Biomed MIS Poly Axial Screw, Open 6.5x40mm 1EA |
| 08806189871088 | L&K Biomed MIS Poly Axial Screw, Open 6.5x35mm 1EA |
| 08806189870388 | L&K Biomed MIS Poly Axial Screw, Open 5.5x35mm 1EA |
| 08806189870357 | L&K Biomed MIS Poly Axial Screw, Open 7.5x55mm 1EA |
| 08806189869979 | L&K Biomed MIS Poly Axial Screw, Open 5.5x40mm 1EA |
| 08806189871248 | L&K Biomed MIS Rod, Straight 5.5x50mm 1EA |
| 08806189871279 | L&K Biomed MIS Rod, Straight 5.5x65mm 1EA |
| 08806189871033 | L&K Biomed MIS Poly Axial Screw, Open 5.5x45mm 1EA |
| 08806189870715 | L&K Biomed MIS Poly Axial Screw, Open 6.5x60mm 1EA |
| 08806189869863 | L&K Biomed MIS Poly Axial Screw, Open 6.5x55mm 1EA |
| 08806189869337 | L&K Biomed MIS Poly Axial Screw, Open 5.5x35mm 1EA |
| 08806189872146 | L&K Biomed MIS Rod, Cuved 5.5x100mm 1EA |
| 08806189872054 | L&K Biomed MIS Rod, Cuved 5.5x55mm 1EA |
| 08806189872030 | L&K Biomed MIS Rod, Cuved 5.5x45mm 1EA |
| 08806189871514 | L&K Biomed MIS Rod, Straight 5.5x270mm 1EA |
| 08806189871491 | L&K Biomed MIS Rod, Straight 5.5x250mm 1EA |
| 08806189871477 | L&K Biomed MIS Rod, Straight 5.5x230mm 1EA |
| 08806189871378 | L&K Biomed MIS Rod, Straight 5.5x130mm 1EA |
| 08806189871194 | L&K Biomed MIS Poly Axial Screw, Open 7.5x55mm 1EA |
| 08806189871132 | L&K Biomed MIS Poly Axial Screw, Open 6.5x60mm 1EA |
| 08806189871095 | L&K Biomed MIS Poly Axial Screw, Open 6.5x40mm 1EA |
| 08806189870999 | L&K Biomed MIS Poly Axial Screw, Open 7.5x60mm 1EA |
| 08806189870821 | L&K Biomed MIS Poly Axial Screw, Open 5.5x45mm 1EA |
| 08806189870647 | L&K Biomed MIS Poly Axial Screw, Open 5.5x60mm 1EA |
| 08806189870630 | L&K Biomed MIS Poly Axial Screw, Open 5.5x55mm 1EA |
| 08806189870494 | L&K Biomed MIS Poly Axial Screw, Open 6.5x55mm 1EA |
| 08806189870425 | L&K Biomed MIS Poly Axial Screw, Open 5.5x55mm 1EA |
| 08806189870401 | L&K Biomed MIS Poly Axial Screw, Open 5.5x45mm 1EA |
| 08806189870272 | L&K Biomed MIS Poly Axial Screw, Open 6.5x50mm 1EA |
| 08806189870234 | L&K Biomed MIS Poly Axial Screw, Open 6.5x30mm 1EA |
| 08806189870227 | L&K Biomed MIS Poly Axial Screw, Open 5.5x60mm 1EA |
| 08806189870098 | L&K Biomed MIS Poly Axial Screw, Open 7.5x30mm 1EA |
| 08806189870081 | L&K Biomed MIS Poly Axial Screw, Open 6.5x60mm 1EA |
| 08806189870036 | L&K Biomed MIS Poly Axial Screw, Open 6.5x35mm 1EA |
| 08806189869856 | L&K Biomed MIS Poly Axial Screw, Open 6.5x50mm 1EA |
| 08806189869474 | L&K Biomed MIS Poly Axial Screw, Open 7.5x35mm 1EA |
| 08806189869382 | L&K Biomed MIS Poly Axial Screw, Open 5.5x60mm 1EA |
| 08806189872191 | L&K Biomed MIS Rod, Cuved 5.5x150mm 1EA |
| 08806189872184 | L&K Biomed MIS Rod, Cuved 5.5x140mm 1EA |
| 08806189872177 | L&K Biomed MIS Rod, Cuved 5.5x130mm 1EA |
| 08806189872160 | L&K Biomed MIS Rod, Cuved 5.5x120mm 1EA |
| 08806189872153 | L&K Biomed MIS Rod, Cuved 5.5x110mm 1EA |