5 MM BONE SCREW X 58 MM

GUDID M209213660

BIOPRO, INC.

Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: M209213660
• NIH Device Record Key: 1fcdf209-e2a0-4a76-81a6-8a1187e1e397
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 5 MM BONE SCREW X 58 MM
• Version Model Number: 21366
• 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: 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	M209213660 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163627

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

[M209213660]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-05-09
• Device Publish Date: 2019-05-01

On-Brand Devices [5 MM BONE SCREW X 58 MM ]

• M209213660: 21366
• M209214260: 21426