PediLoc Fragment System 00-1005-2304

GUDID 00840194466615

2.7mm Locking T-Plate, 2 Hole Head, 4 Hole

ORTHOPEDIATRICS CORP.

Orthopaedic fixation plate, non-bioabsorbable

• Primary Device ID: 00840194466615
• NIH Device Record Key: 854180d2-cdb9-4182-9a43-a1d62e4e463f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PediLoc Fragment System
• Version Model Number: 00-1005-2304
• Catalog Number: 00-1005-2304
• Company DUNS: 796416191
• Company Name: ORTHOPEDIATRICS CORP.
• 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: 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	00840194466615 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140431

FDA Product Code

• HRS: Plate, fixation, bone

Sterilization

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

[00840194466615]

Moist Heat or Steam Sterilization

[00840194466615]

Moist Heat or Steam Sterilization

[00840194466615]

Moist Heat or Steam Sterilization

[00840194466615]

Moist Heat or Steam Sterilization

[00840194466615]

Moist Heat or Steam Sterilization

[00840194466615]

Moist Heat or Steam Sterilization

[00840194466615]

Moist Heat or Steam Sterilization

[00840194466615]

Moist Heat or Steam Sterilization

[00840194466615]

Moist Heat or Steam Sterilization

[00840194466615]

Moist Heat or Steam Sterilization

[00840194466615]

Moist Heat or Steam Sterilization

[00840194466615]

Moist Heat or Steam Sterilization

[00840194466615]

Moist Heat or Steam Sterilization

[00840194466615]

Moist Heat or Steam Sterilization

[00840194466615]

Moist Heat or Steam Sterilization

[00840194466615]

Moist Heat or Steam Sterilization

[00840194466615]

Moist Heat or Steam Sterilization

[00840194466615]

Moist Heat or Steam Sterilization

[00840194466615]

Moist Heat or Steam Sterilization

[00840194466615]

Moist Heat or Steam Sterilization

[00840194466615]

Moist Heat or Steam Sterilization

[00840194466615]

Moist Heat or Steam Sterilization

[00840194466615]

Moist Heat or Steam Sterilization

[00840194466615]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-02-16
• Device Publish Date: 2024-02-08

On-Brand Devices [PediLoc Fragment System]

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• 00841132113448: 4.0mm Cannulated Cancellous Screw, partial thread, T15, 42mm
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• 00841132113363: 4.0mm Cannulated Cancellous Screw, partial thread, T15, 28mm
• 00841132113356: 4.0mm Cannulated Cancellous Screw, partial thread, T15, 26mm
• 00841132113349: 4.0mm Cannulated Cancellous Screw, partial thread, T15, 25mm
• 00841132113332: 4.0mm Cannulated Cancellous Screw, partial thread, T15, 24mm
• 00841132113325: 4.0mm Cannulated Cancellous Screw, partial thread, T15, 22mm
• 00841132113318: 4.0mm Cannulated Cancellous Screw, partial thread, T15, 20mm
• 00841132113301: 4.0mm Cannulated Cancellous Screw, partial thread, T15, 18mm
• 00841132113295: 4.0mm Cannulated Cancellous Screw, partial thread, T15, 16mm
• 00841132113288: 4.0mm Cannulated Cancellous Screw, partial thread, T15, 15mm
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