5 MM BONE SCREW X 36 MM

GUDID M209214150

BIOPRO, INC.

Orthopaedic bone screw, non-bioabsorbable, sterile

• Primary Device ID: M209214150
• NIH Device Record Key: be0541b7-4828-4d52-a2cf-5e4c5dd32715
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 5 MM BONE SCREW X 36 MM
• Version Model Number: 21415
• 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	M209214150 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163627

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: 2019-06-20
• Device Publish Date: 2019-06-12

On-Brand Devices [5 MM BONE SCREW X 36 MM ]

• M209213550: 21355
• M209214150: 21415