PIT'STOP®

GUDID 03760225713358

IN2BONES

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile

• Primary Device ID: 03760225713358
• NIH Device Record Key: a2e9f1bc-5819-4c18-90ef-4368ee81c2f1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PIT'STOP®
• Version Model Number: M20 SP012
• Company DUNS: 263616749
• Company Name: IN2BONES
• 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

Customer Support Contacts

• Phone: +33472292626
• Email: contact@in2bones.com

Device Dimensions

• Length: 14.4 Millimeter
• Width: 12 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	03760225713358 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170688

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2024-02-19
• Device Publish Date: 2018-04-20