Large Fragment Active Plating System

GUDID 00866204000242

5mm Locking Screw, 28mm

Incipio Devices

Hip internal fixation system

• Primary Device ID: 00866204000242
• NIH Device Record Key: 4b1e43da-2d4f-42a2-a880-838af460c1cc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Large Fragment Active Plating System
• Version Model Number: 00-505-000-28
• Company DUNS: 042094056
• Company Name: Incipio Devices
• 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
GS1	00866204000242 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142938

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

[00866204000242]

Moist Heat or Steam Sterilization

[00866204000242]

Moist Heat or Steam Sterilization

[00866204000242]

Moist Heat or Steam Sterilization

[00866204000242]

Moist Heat or Steam Sterilization

[00866204000242]

Moist Heat or Steam Sterilization

[00866204000242]

Moist Heat or Steam Sterilization

[00866204000242]

Moist Heat or Steam Sterilization

[00866204000242]

Moist Heat or Steam Sterilization

[00866204000242]

Moist Heat or Steam Sterilization

[00866204000242]

Moist Heat or Steam Sterilization

[00866204000242]

Moist Heat or Steam Sterilization

[00866204000242]

Moist Heat or Steam Sterilization

[00866204000242]

Moist Heat or Steam Sterilization

[00866204000242]

Moist Heat or Steam Sterilization

[00866204000242]

Moist Heat or Steam Sterilization

[00866204000242]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-02-24

On-Brand Devices [Large Fragment Active Plating System]

• 00866204000266: 5mm Locking Screw, 34mm
• 00866204000259: 5mm Locking Screw, 30mm
• 00866204000242: 5mm Locking Screw, 28mm
• 00866204000235: 5mm Locking Screw, 26mm
• 00866204000228: 5mm Locking Screw, 24mm
• 00866204000211: Large fragment plate, 9 hole, 205 mm
• 00866204000204: Large fragment plate, 7 hole, 165 mm