Spinous Process Plate, 12mm

GUDID 00810131880811

SURGENTEC, LLC

Lumbar decompression interspinous spacer

• Primary Device ID: 00810131880811
• NIH Device Record Key: 46dfe56c-067d-4e82-98cc-4a467d3d02b5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spinous Process Plate, 12mm
• Version Model Number: SR08-4612
• Company DUNS: 004095409
• Company Name: SURGENTEC, LLC
• 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	00810131880811 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101525
• Premarket Notification: K110367

FDA Product Code

• KWP: Appliance, Fixation, Spinal Interlaminal

Sterilization

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

[00810131880811]

Moist Heat or Steam Sterilization

[00810131880811]

Moist Heat or Steam Sterilization

[00810131880811]

Moist Heat or Steam Sterilization

[00810131880811]

Moist Heat or Steam Sterilization

[00810131880811]

Moist Heat or Steam Sterilization

[00810131880811]

Moist Heat or Steam Sterilization

[00810131880811]

Moist Heat or Steam Sterilization

[00810131880811]

Moist Heat or Steam Sterilization

[00810131880811]

Moist Heat or Steam Sterilization

[00810131880811]

Moist Heat or Steam Sterilization

[00810131880811]

Moist Heat or Steam Sterilization

[00810131880811]

Moist Heat or Steam Sterilization

[00810131880811]

Moist Heat or Steam Sterilization

[00810131880811]

Moist Heat or Steam Sterilization

[00810131880811]

Moist Heat or Steam Sterilization

[00810131880811]

Moist Heat or Steam Sterilization

[00810131880811]

Moist Heat or Steam Sterilization

[00810131880811]

Moist Heat or Steam Sterilization

[00810131880811]

Moist Heat or Steam Sterilization

[00810131880811]

Moist Heat or Steam Sterilization

[00810131880811]

Moist Heat or Steam Sterilization

[00810131880811]

Moist Heat or Steam Sterilization

[00810131880811]

Moist Heat or Steam Sterilization

[00810131880811]

Moist Heat or Steam Sterilization

[00810131880811]

Moist Heat or Steam Sterilization

[00810131880811]

Moist Heat or Steam Sterilization

[00810131880811]

Moist Heat or Steam Sterilization

[00810131880811]

Moist Heat or Steam Sterilization

[00810131880811]

Moist Heat or Steam Sterilization

[00810131880811]

Moist Heat or Steam Sterilization

[00810131880811]

Moist Heat or Steam Sterilization

[00810131880811]

Moist Heat or Steam Sterilization

[00810131880811]

Moist Heat or Steam Sterilization

[00810131880811]

Moist Heat or Steam Sterilization

[00810131880811]

Moist Heat or Steam Sterilization

[00810131880811]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-01-13
• Device Publish Date: 2025-01-03

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• 00810131881429 - OsteoFlo HydroFiber - 1cc Labeled: 2026-03-17
• 00810131881436 - OsteoFlo HydroFiber - 3cc Labeled: 2026-03-17
• 00810131881443 - OsteoFlo HydroFiber - 6cc Labeled: 2026-03-17
• 00810131881450 - OsteoFlo HydroFiber - 12cc Labeled: 2026-03-17
• 00810131881726 - ION Facet Screw System: 2026-03-17 ION Facet Screw - 7.0 x 10mm