LnK Spinal Instrument System CS02-CM16

GUDID 08806344397330

DUAL END SET SCREW DRIVER

L&K BIOMED CO. ,LTD.

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• Primary Device ID: 08806344397330
• NIH Device Record Key: 6ca7cc4b-0a74-4007-a7b6-44fad24b8fab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LnK Spinal Instrument System
• Version Model Number: CS02-CM16
• Catalog Number: CS02-CM16
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	08806344397330 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[08806344397330]

Moist Heat or Steam Sterilization

[08806344397330]

Moist Heat or Steam Sterilization

[08806344397330]

Moist Heat or Steam Sterilization

[08806344397330]

Moist Heat or Steam Sterilization

[08806344397330]

Moist Heat or Steam Sterilization

[08806344397330]

Moist Heat or Steam Sterilization

[08806344397330]

Moist Heat or Steam Sterilization

[08806344397330]

Moist Heat or Steam Sterilization

[08806344397330]

Moist Heat or Steam Sterilization

[08806344397330]

Moist Heat or Steam Sterilization

[08806344397330]

Moist Heat or Steam Sterilization

[08806344397330]

Moist Heat or Steam Sterilization

[08806344397330]

Moist Heat or Steam Sterilization

[08806344397330]

Moist Heat or Steam Sterilization

[08806344397330]

Moist Heat or Steam Sterilization

[08806344397330]

Moist Heat or Steam Sterilization

[08806344397330]

Moist Heat or Steam Sterilization

[08806344397330]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-01-30
• Device Publish Date: 2024-01-22

On-Brand Devices [LnK Spinal Instrument System]

• 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