MIDLINE II-Ti M391516c-35

GUDID 00840402507567

MIDLINE II-Ti M391516c-35

Silony Medical Corp

Metal-polymer composite spinal interbody fusion cage

• Primary Device ID: 00840402507567
• NIH Device Record Key: 68041c35-48d3-4f86-b44b-6f6795930145
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MIDLINE II-Ti
• Version Model Number: M391516c-35
• Catalog Number: M391516c-35
• 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	00840402507567 [Primary]
GS1	00843193111654 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130461

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 [MIDLINE II-Ti]

• 00840402508250: MIDLINE II-Ti 42mm x 21mm x 16°
• 00840402508151: MIDLINE II-Ti 42mm x 19mm x 12°
• 00840402508014: MIDLINE II-Ti 42mm x 15mm x 16°
• 00840402507994: MIDLINE II-Ti 42mm x 15mm x 12°
• 00840402507932: MIDLINE II-Ti 42mm x 13mm x 12°
• 00840402507895: MIDLINE II-Ti 42mm x 11mm x 12°
• 00840402507857: MIDLINE II-Ti 39mm x 21mm x 20°
• 00840402507833: MIDLINE II-Ti 39mm x 21mm x 16°
• 00840402507819: MIDLINE II-Ti 39mm x 21mm x 12°
• 00840402507772: MIDLINE II-Ti 39mm x 19mm x 20°
• 00840402507734: MIDLINE II-Ti 39mm x 19mm x 12°
• 00840402507697: MIDLINE II-Ti 39mm x 17mm x 20°
• 00840402507635: MIDLINE II-Ti 39mm x 17mm x 12°
• 00840402507567: MIDLINE II-Ti M391516c-35
• 00840402507550: MIDLINE II-Ti 39mm x 15mm x 16°
• 00840402507475: MIDLINE II-Ti 39mm x 13mm x 16°
• 00840402507451: MIDLINE II-Ti M391312c-35
• 00840402507444: MIDLINE II-Ti 39mm x 13mm x 12°
• 00840402507420: MIDLINE II-Ti M391308c-35
• 00840402507390: MIDLINE II-Ti 39mm x 11mm x 12°
• 00840402507352: MIDLINE II-Ti 36mm x 21mm x 20°
• 00840402507338: MIDLINE II-Ti 36mm x 21mm x 16°
• 00840402507314: MIDLINE II-Ti 36mm x 21mm x 12°
• 00840402507277: MIDLINE II-Ti 36mm x 19mm x 20°
• 00840402507239: MIDLINE II-Ti 36mm x 19mm x 12°
• 00840402507147: MIDLINE II-Ti 36mm x 17mm x 12°
• 00840402507048: MIDLINE II-Ti 36mm x 15mm x 12°
• 00840402507024: MIDLINE II-Ti M361508c-32
• 00840402506997: MIDLINE II-Ti 36mm x 13mm x 20°
• 00840402506959: MIDLINE II-Ti M361312c-32
• 00840402506898: MIDLINE II-Ti 36mm x 11mm x 12°
• 00840402506850: MIDLINE II-Ti 33mm x 21mm x 20°
• 00840402506751: MIDLINE II-Ti 33mm x 19mm x 16°
• 00840402506690: MIDLINE II-Ti 33mm x 17mm x 20°
• 00840402506652: MIDLINE II-Ti 33mm x 17mm x 12°
• 00840402506591: MIDLINE II-Ti 33mm x 15mm x 16°
• 00840402506577: MIDLINE II-Ti 33mm x 15mm x 12°
• 00840402506539: MIDLINE II-Ti 33mm x 13mm x 20°
• 00840402506515: MIDLINE II-Ti 33mm x 13mm x 16°
• 00840402506492: MIDLINE II-Ti 33mm x 13mm x 12°
• 00840402506454: MIDLINE II-Ti 33mm x 11mm x 12°
• 00840402506393: MIDLINE II-Ti 30mm x 21mm x 16°
• 00840402506331: MIDLINE II-Ti 30mm x 19mm x 20°
• 00840402506294: MIDLINE II-Ti 30mm x 19mm x 12°
• 00840402506270: MIDLINE II-Ti 30mm x 19mm x 8°
• 00840402506232: MIDLINE II-Ti 30mm x 17mm x 16°
• 00840402506218: MIDLINE II-Ti 30mm x 17mm x 12°
• 00840402506157: MIDLINE II-Ti 30mm x 15mm x 16°
• 00840402506133: MIDLINE II-Ti 30mm x 15mm x 12°
• 00840402506119: MIDLINE II-Ti 30mm x 15mm x 8°