Horizon Subtalar Complete Kit

GUDID M20922797

BIOPRO, INC.

Orthopaedic surgical procedure kit, non-medicated, reusable

• Primary Device ID: M20922797
• NIH Device Record Key: 464a26a9-f49e-4bfb-820a-dc7bc8edd867
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Horizon Subtalar Complete Kit
• Version Model Number: 22797
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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
HIBCC	M20922797 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041936

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[M20922797]

Moist Heat or Steam Sterilization

[M20922797]

Moist Heat or Steam Sterilization

[M20922797]

Moist Heat or Steam Sterilization

[M20922797]

Moist Heat or Steam Sterilization

[M20922797]

Moist Heat or Steam Sterilization

[M20922797]

Moist Heat or Steam Sterilization

[M20922797]

Moist Heat or Steam Sterilization

[M20922797]

Moist Heat or Steam Sterilization

[M20922797]

Moist Heat or Steam Sterilization

[M20922797]

Moist Heat or Steam Sterilization

[M20922797]

Moist Heat or Steam Sterilization

[M20922797]

Moist Heat or Steam Sterilization

[M20922797]

Moist Heat or Steam Sterilization

[M20922797]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-01
• Device Publish Date: 2020-09-23

On-Brand Devices [Horizon Subtalar Complete Kit]

• M209173070: 17307
• M20922797: 22797