MTP FUSION PLATE, NARROW 0 DEGREE, LEFT

GUDID M20923807

BIOPRO, INC.

Orthopaedic fixation plate, non-bioabsorbable

• Primary Device ID: M20923807
• NIH Device Record Key: cbee6253-2e55-4af9-90a7-97de2e62cd41
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MTP FUSION PLATE, NARROW 0 DEGREE, LEFT
• Version Model Number: 23087
• Company DUNS: 618749857
• Company Name: BIOPRO, INC.
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M20923807 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162674

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

[M20923807]

Moist Heat or Steam Sterilization

[M20923807]

Moist Heat or Steam Sterilization

[M20923807]

Moist Heat or Steam Sterilization

[M20923807]

Moist Heat or Steam Sterilization

[M20923807]

Moist Heat or Steam Sterilization

[M20923807]

Moist Heat or Steam Sterilization

[M20923807]

Moist Heat or Steam Sterilization

[M20923807]

Moist Heat or Steam Sterilization

[M20923807]

Moist Heat or Steam Sterilization

[M20923807]

Moist Heat or Steam Sterilization

[M20923807]

Moist Heat or Steam Sterilization

[M20923807]

Moist Heat or Steam Sterilization

[M20923807]

Moist Heat or Steam Sterilization

[M20923807]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-04-03
• Device Publish Date: 2024-03-26

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• M209178080 - THUMB MOD HEAD TITANIUM 15MM: 2024-07-08
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• M209177980 - THUMB MOD HEAD TITANIUM 13MM: 2024-06-07