STALIF MIDLINE STM6025R

GUDID 00840402519768

STALIF MIDLINE Revision Screw, Ø6.0 x 25

Silony Medical Corp

Spinal bone screw, non-bioabsorbable

• Primary Device ID: 00840402519768
• NIH Device Record Key: a4a2af2b-4757-46db-82e6-e286e3a162c0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STALIF MIDLINE
• Version Model Number: STM6025R
• Catalog Number: STM6025R
• Company DUNS: 106081213
• Company Name: Silony Medical Corp
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815101029320 [Previous]
GS1	00840402519768 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141942

FDA Product Code

• OVD: Intervertebral fusion device with integrated fixation, lumbar

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-02
• Device Publish Date: 2025-11-24

On-Brand Devices [STALIF MIDLINE]

• 00840402519782: STALIF MIDLINE Revision Screw, Ø6.0 x 30
• 00840402519775: STALIF MIDLINE Screw, Ø6.0mm x 30mm
• 00840402519768: STALIF MIDLINE Revision Screw, Ø6.0 x 25