MIDLINE II M391908

GUDID 00840402507703

MIDLINE II 39mm x 19mm x 8°

Silony Medical Corp

Polymeric spinal interbody fusion cage

• Primary Device ID: 00840402507703
• NIH Device Record Key: 422d734e-05cb-4d45-8908-14b20c598415
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MIDLINE II
• Version Model Number: M391908
• Catalog Number: M391908
• Company DUNS: 106081213
• Company Name: Silony Medical Corp
• Device Count: 1
• DM Exempt: false
• 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: 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	00815101020723 [Previous]
GS1	00840402507703 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133286

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]

• 00840402508267: MIDLINE II 42mm x 21mm x 20°
• 00840402508182: MIDLINE II 42mm x 19mm x 20°
• 00840402508021: MIDLINE II 42mm x 15mm x 20°
• 00840402507963: MIDLINE II 42mm x 15mm x 8°
• 00840402507864: MIDLINE II 42mm x 11mm x 8°
• 00840402507727: MIDLINE II 39mm x 19mm x 12°
• 00840402507703: MIDLINE II 39mm x 19mm x 8°
• 00840402507659: MIDLINE II 39mm x 17mm x 16°
• 00840402507574: MIDLINE II 39mm x 15mm x 20°
• 00840402507543: MIDLINE II 39mm x 15mm x 16°
• 00840402507512: MIDLINE II 39mm x 15mm x 12°
• 00840402507482: MIDLINE II 39mm x 15mm x 8°
• 00840402507369: MIDLINE II 39mm x 11mm x 8°
• 00840402507321: MIDLINE II 36mm x 21mm x 16°
• 00840402507307: MIDLINE II 36mm x 21mm x 12°
• 00840402507284: MIDLINE II 36mm x 21mm x 8°
• 00840402507260: MIDLINE II 36mm x 19mm x 20°
• 00840402507185: MIDLINE II 36mm x 17mm x 20°
• 00840402507161: MIDLINE II 36mm x 17mm x 16°
• 00840402507130: MIDLINE II 36mm x 17mm x 12°
• 00840402507062: MIDLINE II 36mm x 15mm x 16°
• 00840402507031: MIDLINE II 36mm x 15mm x 12°
• 00840402507000: MIDLINE II 36mm x 15mm x 8°
• 00840402506966: MIDLINE II 36mm x 13mm x 16°
• 00840402506881: MIDLINE II 36mm x 11mm x 12°
• 00840402506867: MIDLINE II 36mm x 11mm x 8°
• 00840402506829: MIDLINE II 33mm x 21mm x 16°
• 00840402506805: MIDLINE II 33mm x 21mm x 12°
• 00840402506782: MIDLINE II 33mm x 21mm x 8°
• 00840402506768: MIDLINE II 33mm x 19mm x 20°
• 00840402506683: MIDLINE II 33mm x 17mm x 20°
• 00840402506669: MIDLINE II 33mm x 17mm x 16°
• 00840402506645: MIDLINE II 33mm x 17mm x 12°
• 00840402506560: MIDLINE II 33mm x 15mm x 12°
• 00840402506461: MIDLINE II 33mm x 13mm x 8°
• 00840402506423: MIDLINE II 33mm x 11mm x 8°
• 00840402506362: MIDLINE II 30mm x 21mm x 12°
• 00840402506300: MIDLINE II 30mm x 19mm x 16°
• 00840402506287: MIDLINE II 30mm x 19mm x 12°
• 00840402506263: MIDLINE II 30mm x 19mm x 8°
• 00840402506249: MIDLINE II 30mm x 17mm x 20°
• 00840402506102: MIDLINE II 30mm x 15mm x 8°
• 00840402506003: MIDLINE II 30mm x 11mm x 12°