| Primary Device ID | 08806344363236 |
| NIH Device Record Key | 8bc07ef0-3dd7-4e1a-b3da-0354ef76865f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PathLoc-SI Joint Fusion System |
| Version Model Number | 1203-0008 |
| 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 | 08806344363236 [Primary] |
| OUR | Sacroiliac Joint Fixation |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08806344363236]
Moist Heat or Steam Sterilization
[08806344363236]
Moist Heat or Steam Sterilization
[08806344363236]
Moist Heat or Steam Sterilization
[08806344363236]
Moist Heat or Steam Sterilization
[08806344363236]
Moist Heat or Steam Sterilization
[08806344363236]
Moist Heat or Steam Sterilization
[08806344363236]
Moist Heat or Steam Sterilization
[08806344363236]
Moist Heat or Steam Sterilization
[08806344363236]
Moist Heat or Steam Sterilization
[08806344363236]
Moist Heat or Steam Sterilization
[08806344363236]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2022-11-28 |
| Device Publish Date | 2018-10-01 |
| 08806344363809 | Washer |
| 08806344363793 | Washer |
| 08806344363786 | Washer |
| 08806344363779 | Locking Screw Ø 8.0 70mm |
| 08806344363762 | Locking Screw Ø 8.0 65mm |
| 08806344363755 | Locking Screw Ø 8.0 60mm |
| 08806344363748 | Locking Screw Ø 8.0 55mm |
| 08806344363731 | Locking Screw Ø 8.0 50mm |
| 08806344363724 | Locking Screw Ø 8.0 45mm |
| 08806344363717 | Locking Screw Ø 8.0 40mm |
| 08806344363700 | Locking Screw Ø 8.0 35mm |
| 08806344363694 | Locking Screw Ø 8.0 30mm |
| 08806344363687 | Locking Screw Ø 7.0 70mm |
| 08806344363670 | Locking Screw Ø 7.0 65mm |
| 08806344363663 | Locking Screw Ø 7.0 60mm |
| 08806344363656 | Locking Screw Ø 7.0 55mm |
| 08806344363649 | Locking Screw Ø 7.0 50mm |
| 08806344363632 | Locking Screw Ø 7.0 45mm |
| 08806344363625 | Locking Screw Ø 7.0 40mm |
| 08806344363618 | Locking Screw Ø 7.0 35mm |
| 08806344363601 | Locking Screw Ø 7.0 30mm |
| 08806344363595 | Locking Screw Ø 6.0 70mm |
| 08806344363588 | Locking Screw Ø 6.0 65mm |
| 08806344363571 | Locking Screw Ø 6.0 60mm |
| 08806344363564 | Locking Screw Ø 6.0 55mm |
| 08806344363557 | Locking Screw Ø 6.0 50mm |
| 08806344363540 | Locking Screw Ø 6.0 45mm |
| 08806344363533 | Locking Screw Ø 6.0 40mm |
| 08806344363526 | Locking Screw Ø 6.0 35mm |
| 08806344363519 | Locking Screw Ø 6.0 30mm |
| 08806344363502 | Arch Screw Close Type 70mm |
| 08806344363496 | Arch Screw Close Type 65mm |
| 08806344363489 | Arch Screw Close Type 60mm |
| 08806344363472 | Arch Screw Close Type 55mm |
| 08806344363465 | Arch Screw Close Type 50mm |
| 08806344363458 | Arch Screw Close Type 45mm |
| 08806344363441 | Arch Screw Close Type 40mm |
| 08806344363434 | Arch Screw Close Type 35mm |
| 08806344363427 | Arch Screw Close Type 30mm |
| 08806344363410 | Arch Screw Open Type 70mm |
| 08806344363403 | Arch Screw Open Type 65mm |
| 08806344363397 | Arch Screw Open Type 60mm |
| 08806344363380 | Arch Screw Open Type 55mm |
| 08806344363373 | Arch Screw Open Type 50mm |
| 08806344363366 | Arch Screw Open Type 45mm |
| 08806344363359 | Arch Screw Open Type 40mm |
| 08806344363342 | Arch Screw Open Type 35mm |
| 08806344363335 | Arch Screw Open Type 30mm |
| 08806344363328 | Locking Screw Ø 8.0 70mm |
| 08806344363311 | Locking Screw Ø 8.0 65mm |