PUMA SYSTEM

GUDID B671FA0017B0

PANTHER ORTHOPEDICS, INC.

Orthopaedic bone bolt

• Primary Device ID: B671FA0017B0
• NIH Device Record Key: 1a4b9de8-b02d-4597-936d-c0d563c2d22b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PUMA SYSTEM
• Version Model Number: GEN 3
• Company DUNS: 117139687
• Company Name: PANTHER ORTHOPEDICS, 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: false
• 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	B671FA0017B0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171703

FDA Product Code

• HTN: Washer, Bolt Nut

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: 2020-02-21
• Device Publish Date: 2020-02-13