LnK Posterior Cervical Fixation System 6119-3522

GUDID 08806189899044

L&K Biomed Cervical Partially Reduction Screw 3.5x22mm 1EA

L&K BIOMED CO. ,LTD.

Spinal bone screw, non-bioabsorbable

• Primary Device ID: 08806189899044
• NIH Device Record Key: 4894d6ed-fc51-43fb-a02e-29a3cdc3dc64
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LnK Posterior Cervical Fixation System
• Version Model Number: 6119-3522
• Catalog Number: 6119-3522
• 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	08806189899044 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143278

FDA Product Code

• MNI: Orthosis, Spinal Pedicle Fixation

Sterilization

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

[08806189899044]

Moist Heat or Steam Sterilization

[08806189899044]

Moist Heat or Steam Sterilization

[08806189899044]

Moist Heat or Steam Sterilization

[08806189899044]

Moist Heat or Steam Sterilization

[08806189899044]

Moist Heat or Steam Sterilization

[08806189899044]

Moist Heat or Steam Sterilization

[08806189899044]

Moist Heat or Steam Sterilization

[08806189899044]

Moist Heat or Steam Sterilization

[08806189899044]

Moist Heat or Steam Sterilization

[08806189899044]

Moist Heat or Steam Sterilization

[08806189899044]

Moist Heat or Steam Sterilization

[08806189899044]

Moist Heat or Steam Sterilization

[08806189899044]

Moist Heat or Steam Sterilization

[08806189899044]

Moist Heat or Steam Sterilization

[08806189899044]

Moist Heat or Steam Sterilization

[08806189899044]

Moist Heat or Steam Sterilization

[08806189899044]

Moist Heat or Steam Sterilization

[08806189899044]

Moist Heat or Steam Sterilization

[08806189899044]

Moist Heat or Steam Sterilization

[08806189899044]

Moist Heat or Steam Sterilization

[08806189899044]

Moist Heat or Steam Sterilization

[08806189899044]

Moist Heat or Steam Sterilization

[08806189899044]

Moist Heat or Steam Sterilization

[08806189899044]

Moist Heat or Steam Sterilization

[08806189899044]

Moist Heat or Steam Sterilization

[08806189899044]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2024-07-09
• Device Publish Date: 2015-09-22

On-Brand Devices [LnK Posterior Cervical Fixation System]

• 08806189838135: L&K Biomed Rod, Straight, Hex, Titanium 5.5x320mm 1EA
• 08806189898047: L&K Biomed Cervical Semi Reduction Screw 4.0x40mm (3.0 neck)1EA
• 08806189897514: L&K Biomed Cervical Polyaxial Screw 4.0x22mm (3.0 neck)1EA
• 08806189877875: L&K Biomed Cervical Reductionn Screw 3.5x20mm 1EA
• 08806189877547: L&K Biomed Cervical Semi Reductionn Screw 3.5x42mm 1EA
• 08806189877516: L&K Biomed Cervical Semi Reductionn Screw 3.5x36mm 1EA
• 08806189877172: L&K Biomed Cervical Polyaxial Screw 4.0x12mm 1EA
• 08806189876991: L&K Biomed Cervical Polyaxial Screw 3.5x20mm 1EA
• 08806189876953: L&K Biomed Cervical Polyaxial Screw 3.5x12mm 1EA
• 08806189838166: L&K Biomed Rod, Straight, Hex, Titanium 6.0x340mm 1EA
• 08806189878162: L&K Biomed Cervical Reductionn Screw 4.0x34mm 1EA
• 08806189877509: L&K Biomed Cervical Semi Reductionn Screw 3.5x34mm 1EA
• 08806344304789: L&K Biomed Cervical Right Offset Semi Reduction Hook 5.0mm 1EA
• 08806189899662: L&K Biomed Cervical Rod, Curved (CoCrMo) 3.5x170mm 1EA
• 08806189897651: L&K Biomed Cervical Polyaxial Screw 4.0x50mm (3.0 neck)1EA
• 08806189897538: L&K Biomed Cervical Polyaxial Screw 4.0x26mm (3.0 neck)1EA
• 08806189838241: L&K Biomed Rod, Straight, Hex, Titanium 6.0x430mm 1EA
• 08806189838234: L&K Biomed Rod, Straight, Hex, Titanium 6.0x420mm 1EA
• 08806189838227: L&K Biomed Rod, Straight, Hex, Titanium 6.0x410mm 1EA
• 08806189838210: L&K Biomed Rod, Straight, Hex, Titanium 6.0x400mm 1EA
• 08806189838203: L&K Biomed Rod, Straight, Hex, Titanium 6.0x390mm 1EA
• 08806189838197: L&K Biomed Rod, Straight, Hex, Titanium 6.0x380mm 1EA
• 08806189838180: L&K Biomed Rod, Straight, Hex, Titanium 6.0x370mm 1EA
• 08806189838173: L&K Biomed Rod, Straight, Hex, Titanium 6.0x360mm 1EA
• 08806189838159: L&K Biomed Rod, Straight, Hex, Titanium 6.0x340mm 1EA
• 08806189838142: L&K Biomed Rod, Straight, Hex, Titanium 6.0x330mm 1EA
• 08806189838128: L&K Biomed Rod, Straight, Hex, Titanium 6.0x310mm 1EA
• 08806189838111: L&K Biomed Rod, Straight, Hex, Titanium 6.0x300mm 1EA
• 08806189838104: L&K Biomed Rod, Straight, Hex, Titanium 6.0x290mm 1EA
• 08806189838098: L&K Biomed Rod, Straight, Hex, Titanium 6.0x280mm 1EA
• 08806189838081: L&K Biomed Rod, Straight, Hex, Titanium 6.0x270mm 1EA
• 08806189838074: L&K Biomed Rod, Straight, Hex, Titanium 6.0x260mm 1EA
• 08806189838067: L&K Biomed Rod, Straight, Hex, Titanium 6.0x250mm 1EA
• 08806189838050: L&K Biomed Rod, Straight, Hex, Titanium 6.0x240mm 1EA
• 08806189838043: L&K Biomed Rod, Straight, Hex, Titanium 6.0x230mm 1EA
• 08806189838036: L&K Biomed Rod, Straight, Hex, Titanium 6.0x220mm 1EA
• 08806189838029: L&K Biomed Rod, Straight, Hex, Titanium 6.0x210mm 1EA
• 08806189838012: L&K Biomed Rod, Straight, Hex, Titanium 6.0x200mm 1EA
• 08806189838005: L&K Biomed Rod, Straight, Hex, Titanium 6.0x195mm 1EA
• 08806189837992: L&K Biomed Rod, Straight, Hex, Titanium 6.0x190mm 1EA
• 08806189837985: L&K Biomed Rod, Straight, Hex, Titanium 6.0x185mm 1EA
• 08806189898115: L&K Biomed Cervical Reduction Screw 3.5x10mm (3.0 neck)1EA
• 08806189897262: L&K Biomed Cervical Polyaxial Screw 3.5x16mm (3.0 neck)1EA
• 08806189878247: L&K Biomed Cervical Reductionn Screw 4.0x50mm 1EA
• 08806189877721: L&K Biomed Cervical Semi Reductionn Screw 4.0x34mm 1EA
• 08806189877592: L&K Biomed Cervical Semi Reductionn Screw 4.0x08mm 1EA
• 08806344305052: L&K Biomed Cervical Left Offset Reduction Hook 8.0mm 1EA
• 08806344305045: L&K Biomed Cervical Left Offset Reduction Hook 7.0mm 1EA
• 08806344305038: L&K Biomed Cervical Left Offset Reduction Hook 6.0mm 1EA
• 08806344305021: L&K Biomed Cervical Left Offset Reduction Hook 5.0mm 1EA