LnK Spinal Fixation System

GUDID 08806189835332

L&K Biomed Rod, Straight, CoCrMo 6.0x440mm 1EA

L&K BIOMED CO. ,LTD.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 08806189835332
• NIH Device Record Key: a3ea3568-4d13-4349-b354-abd63096faf3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LnK Spinal Fixation System
• Version Model Number: 1071-55440
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	08806189835332 [Primary]

FDA Product Code

• KWP: Appliance, Fixation, Spinal Interlaminal

Sterilization

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

[08806189835332]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-07-01
• Device Publish Date: 2020-06-23

On-Brand Devices [LnK Spinal Fixation System]

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• 08806189837855: L&K Biomed Rod, Straight, Hex, Titanium 5.5x120mm 1EA
• 08806189837848: L&K Biomed Rod, Straight, Hex, Titanium 5.5x115mm 1EA
• 08806189837831: L&K Biomed Rod, Straight, Hex, Titanium 5.5x110mm 1EA
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• 08806189837817: L&K Biomed Rod, Straight, Hex, Titanium 5.5x100mm 1EA
• 08806189800071: L&K Biomed Set Screw-Star for 6.0 Rod 9.7x5.6mm 1EA
• 08806189800064: L&K Biomed Set Screw-Hex for 6.0 Rod 9.7x5.6mm 1EA
• 08806189841500: L&K Biomed Rod, Straight, Hex, CoCrMo 6.0x120mm 1EA
• 08806189837534: L&K Biomed Rod, Straight, Hex, Titanium 5.0x450mm 1EA
• 08806189835783: L&K Biomed Rod, Straight, CoCrMo 6.0x180mm 1EA
• 08806189823438: L&K Biomed Reductionn Poly Axial Screw 4.5x20mm 1EA
• 08806189821793: L&K Biomed Poly Axial Screw 5.0x45mm 1EA
• 08806189810643: L&K Biomed Reductionn Mono Axial Screw 6.0x60mm 1EA
• 08806189810636: L&K Biomed Reductionn Mono Axial Screw 6.0x55mm 1EA
• 08806189810629: L&K Biomed Reductionn Mono Axial Screw 6.0x50mm 1EA
• 08806189810612: L&K Biomed Reductionn Mono Axial Screw 6.0x45mm 1EA
• 08806189810605: L&K Biomed Reductionn Mono Axial Screw 6.0x40mm 1EA
• 08806189810599: L&K Biomed Reductionn Mono Axial Screw 6.0x35mm 1EA
• 08806189810582: L&K Biomed Reductionn Mono Axial Screw 6.0x30mm 1EA
• 08806189810575: L&K Biomed Reductionn Mono Axial Screw 6.0x25mm 1EA
• 08806189810568: L&K Biomed Reductionn Mono Axial Screw 6.0x20mm 1EA
• 08806189804819: L&K Biomed Mono Axial Iliac Screw 6.5x80mm 1EA
• 08806189835332: L&K Biomed Rod, Straight, CoCrMo 6.0x440mm 1EA
• 08806189832065: L&K Biomed Rod, Straight, Titanium 5.5x145mm 1EA