Primary Device ID | 08800108690323 |
NIH Device Record Key | 182fe480-81a2-4e96-bc0b-c79b8f976c40 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | LnK Spinal Instrument System |
Version Model Number | SI01-0602 |
Catalog Number | SI01-0602 |
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 | 08800108690323 [Primary] |
LXH | Orthopedic Manual Surgical Instrument |
Steralize Prior To Use | true |
Device Is Sterile | false |
[08800108690323]
Moist Heat or Steam Sterilization
[08800108690323]
Moist Heat or Steam Sterilization
[08800108690323]
Moist Heat or Steam Sterilization
[08800108690323]
Moist Heat or Steam Sterilization
[08800108690323]
Moist Heat or Steam Sterilization
[08800108690323]
Moist Heat or Steam Sterilization
[08800108690323]
Moist Heat or Steam Sterilization
[08800108690323]
Moist Heat or Steam Sterilization
[08800108690323]
Moist Heat or Steam Sterilization
[08800108690323]
Moist Heat or Steam Sterilization
[08800108690323]
Moist Heat or Steam Sterilization
[08800108690323]
Moist Heat or Steam Sterilization
[08800108690323]
Moist Heat or Steam Sterilization
[08800108690323]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2023-05-03 |
Device Publish Date | 2023-01-10 |
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 |