HORIZON TITANIUM SUBTALAR 8MM

GUDID 00810012480291

BIOPRO, INC.

Subtalar implant, non-bioabsorbable, sterile

• Primary Device ID: 00810012480291
• NIH Device Record Key: 3cf38023-9a04-4c03-b676-0f83b06275af
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HORIZON TITANIUM SUBTALAR 8MM
• Version Model Number: 17221
• Company DUNS: 618749857
• Company Name: BIOPRO, INC.
• 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: true
• 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
GS1	00810012480291 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041936

FDA Product Code

• HWC: Screw, Fixation, Bone

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: 2021-06-22
• Device Publish Date: 2021-06-14

On-Brand Devices [HORIZON TITANIUM SUBTALAR 8MM]

• 00810012480291: 17221
• M209172210: 17221