FacetLink System 80-1011/35

GUDID 04026575426584

Facet Screw

WALDEMAR LINK GmbH & Co. KG

Spinal bone screw, non-bioabsorbable

• Primary Device ID: 04026575426584
• NIH Device Record Key: e23dcb9e-36ca-4043-9f34-8216f3063a6e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FacetLink System
• Version Model Number: 80-1011/35
• Catalog Number: 80-1011/35
• Company DUNS: 315675488
• Company Name: WALDEMAR LINK GmbH & Co. KG
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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: true
• OTC Over-The-Counter: false

Device Dimensions

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Device Identifiers

Device Issuing Agency	Device ID
GS1	04026575426584 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123497

FDA Product Code

• MRW: System, Facet Screw Spinal Device

Sterilization

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

[04026575426584]

Moist Heat or Steam Sterilization

[04026575426584]

Moist Heat or Steam Sterilization

[04026575426584]

Moist Heat or Steam Sterilization

[04026575426584]

Moist Heat or Steam Sterilization

[04026575426584]

Moist Heat or Steam Sterilization

[04026575426584]

Moist Heat or Steam Sterilization

[04026575426584]

Moist Heat or Steam Sterilization

[04026575426584]

Moist Heat or Steam Sterilization

[04026575426584]

Moist Heat or Steam Sterilization

[04026575426584]

Moist Heat or Steam Sterilization

[04026575426584]

Moist Heat or Steam Sterilization

[04026575426584]

Moist Heat or Steam Sterilization

[04026575426584]

Moist Heat or Steam Sterilization

[04026575426584]

Moist Heat or Steam Sterilization

[04026575426584]

Moist Heat or Steam Sterilization

[04026575426584]

Moist Heat or Steam Sterilization

[04026575426584]

Moist Heat or Steam Sterilization

[04026575426584]

Moist Heat or Steam Sterilization

[04026575426584]

Moist Heat or Steam Sterilization

[04026575426584]

Moist Heat or Steam Sterilization

[04026575426584]

Moist Heat or Steam Sterilization

[04026575426584]

Moist Heat or Steam Sterilization

[04026575426584]

Moist Heat or Steam Sterilization

[04026575426584]

Moist Heat or Steam Sterilization

[04026575426584]

Moist Heat or Steam Sterilization

[04026575426584]

Moist Heat or Steam Sterilization

[04026575426584]

Moist Heat or Steam Sterilization

[04026575426584]

Moist Heat or Steam Sterilization

[04026575426584]

Moist Heat or Steam Sterilization

[04026575426584]

Moist Heat or Steam Sterilization

[04026575426584]

Moist Heat or Steam Sterilization

[04026575426584]

Moist Heat or Steam Sterilization

[04026575426584]

Moist Heat or Steam Sterilization

[04026575426584]

Moist Heat or Steam Sterilization

[04026575426584]

Moist Heat or Steam Sterilization

[04026575426584]

Moist Heat or Steam Sterilization

[04026575426584]

Moist Heat or Steam Sterilization

[04026575426584]

Moist Heat or Steam Sterilization

[04026575426584]

Moist Heat or Steam Sterilization

[04026575426584]

Moist Heat or Steam Sterilization

[04026575426584]

Moist Heat or Steam Sterilization

[04026575426584]

Moist Heat or Steam Sterilization

[04026575426584]

Moist Heat or Steam Sterilization

[04026575426584]

Moist Heat or Steam Sterilization

[04026575426584]

Moist Heat or Steam Sterilization

[04026575426584]

Moist Heat or Steam Sterilization

[04026575426584]

Moist Heat or Steam Sterilization

[04026575426584]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-04-09
• Device Publish Date: 2015-11-01

On-Brand Devices [FacetLink System]

• 04026575426621: Facet Screw
• 04026575426614: Facet Screw
• 04026575426607: Facet Screw
• 04026575426591: Facet Screw
• 04026575426584: Facet Screw
• 04026575426577: Facet Screw
• 04026575426560: Facet Screw
• 04026575421084: Facet Screw
• 04026575421077: Facet Screw
• 04026575421060: Facet Screw
• 04026575421053: Facet Screw
• 04026575421046: Facet Screw
• 04026575421039: Facet Screw
• 04026575421022: Facet Screw
• 04026575420889: Facet Screw
• 04026575420872: Facet Screw
• 04026575420865: Facet Screw
• 04026575420858: Facet Screw
• 04026575420841: Facet Screw
• 04026575420834: Facet Screw
• 04026575420827: Facet Screw
• 04026575081554: Facet Screw
• 04026575081547: Facet Screw
• 04026575081530: Facet Screw
• 04026575081523: Facet Screw
• 04026575081516: Facet Screw
• 04026575081509: Facet Screw
• 04026575081493: Facet Screw
• 04026575421206: HEMI Implant
• 04026575421190: HEMI Implant
• 04026575421183: HEMI Implant
• 04026575421176: HEMI Implant
• 04026575421169: HEMI Implant
• 04026575421152: HEMI Implant
• 04026575421145: HEMI Implant
• 04026575421138: HEMI Implant
• 04026575421121: HEMI Implant
• 04026575421114: HEMI Implant
• 04026575421107: HEMI Implant
• 04026575421091: HEMI Implant
• 04026575420919: MINI Device
• 04026575420896: Polyaxial Washer