| Primary Device ID | 08809986468925 |
| NIH Device Record Key | e8b82a9c-db0c-4a38-b0c4-7d6085a81623 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | LnK Spinal Instrument System |
| Version Model Number | LS05-2245W |
| Company DUNS | 631159324 |
| Company Name | L&K BIOMED CO. ,LTD. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | false |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08809986468925 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08809986468925]
Moist Heat or Steam Sterilization
[08809986468925]
Moist Heat or Steam Sterilization
[08809986468925]
Moist Heat or Steam Sterilization
[08809986468925]
Moist Heat or Steam Sterilization
[08809986468925]
Moist Heat or Steam Sterilization
[08809986468925]
Moist Heat or Steam Sterilization
[08809986468925]
Moist Heat or Steam Sterilization
[08809986468925]
Moist Heat or Steam Sterilization
[08809986468925]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-09-17 |
| Device Publish Date | 2025-09-09 |
| 08800108688672 | TORQUE LIMIT T-HANDLE |
| 08800108673104 | TAP Ø3.5 |
| 08800108673098 | TAP Ø3.0 |
| 08800108671780 | ADJUSTABLE DRILL GUIDE |
| 08800108665017 | DRILL BIT Ø2.6 OVER 20MM |
| 08800108665604 | SET SCREW DRIVER ADAPTOR |
| 08800108699951 | Cage inserter No gauge |
| 08800108698862 | PathLoc-SI Instrument Lower Tray |
| 08800108698855 | PathLoc-SI Instrument Middle Tray |
| 08800108698848 | PathLoc-SI Instrument Upper Tray |
| 08800108698831 | PathLoc-SI Instrument Container Base |
| 08800108698824 | PathLoc-SI Instrument Container Cover |
| 08800108696929 | MODULAR I HANDLE 1/4 SQUARE |
| 08800108696912 | 3NM TORQUE LIMITING I HANDLE |
| 08800108690323 | BONE FUNNEL INSERTER |
| 08800108690316 | BONE FUNNEL |
| 08800108688450 | 1/4" SQUARE RATCHET I-HANDLE |
| 08800108675122 | GUIDE PIN (THREAD) 600M |
| 08800108674125 | BONE GRAFT PACKING BLOCK |
| 08800108674026 | GUIDE PIN (CLEAR) |
| 08800108671650 | GUIDE PIN (THREAD) |
| 08800108671643 | GUIDE PIN (BLUNT) |
| 08800108699944 | Bone Funnel |
| 08800108699937 | Bone Funnel Inserter |
| 08800108699746 | Trial (22x50x6Hx6D) |
| 08800108699739 | Trial (22x50x8Hx6D) |
| 08800108699722 | Trial (22x50x10Hx6D) |
| 08800108699715 | Trial (22x50x6Hx12D) |
| 08800108699708 | Trial (22x50x8Hx12D) |
| 08800108699692 | Trial (22x50x10Hx12D) |
| 08800108697612 | Guide Pin Thread 300mm |
| 08800108697605 | Guide Pin Thread 400mm |
| 08800108697551 | Reduction Poly Screw Driver With Tracker |
| 08800108691528 | DEROTATOR |
| 08800108689358 | REDUCTION CUTTER |
| 08800108674002 | SLIDING HAMMER (EXTENSION LAM) |
| 08800108673548 | TAP 5.5 (DOUBLE THREAD) |
| 08800108667288 | SHARP REAMER RING TYPE 12MM |
| 08800108667271 | SHARP REAMER RING TYPE 10MM |
| 08800108667264 | SHARP REAMER RING TYPE 8MM |
| 08800108666908 | TRIAL STRAIGHT 18W/8MM |
| 08800108666854 | TRIAL 10mm (assembled) |
| 08800108666830 | TRIAL 8mm (assembled) |
| 08800108666359 | LINK TORQUE LIMITING DRIVER |
| 08800108666212 | ROCKER |
| 08800108666168 | ROD PUSHER |
| 08800108666144 | ROD HOLDER |
| 08800108665543 | PIN CUTTER |
| 08800108665529 | SET SCREW FIRST DRIVER |
| 08800108665277 | CROSS LINK ANTI-TORQUE DEVICE |