Omni Lapidus Plating

GUDID 00842078130919

SlotLock Lapidus Plate, 5-Hole, Right

EXTREMITY MEDICAL, LLC

Orthopaedic fixation plate, non-bioabsorbable

• Primary Device ID: 00842078130919
• NIH Device Record Key: 650371ae-9317-4257-a724-b7192430ccf4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Omni Lapidus Plating
• Version Model Number: 164-21402
• Company DUNS: 832720358
• Company Name: EXTREMITY MEDICAL, LLC
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842078130919 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221362

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

[00842078130919]

Moist Heat or Steam Sterilization

[00842078130919]

Moist Heat or Steam Sterilization

[00842078130919]

Moist Heat or Steam Sterilization

[00842078130919]

Moist Heat or Steam Sterilization

[00842078130919]

Moist Heat or Steam Sterilization

[00842078130919]

Moist Heat or Steam Sterilization

[00842078130919]

Moist Heat or Steam Sterilization

[00842078130919]

Moist Heat or Steam Sterilization

[00842078130919]

Moist Heat or Steam Sterilization

[00842078130919]

Moist Heat or Steam Sterilization

[00842078130919]

Moist Heat or Steam Sterilization

[00842078130919]

Moist Heat or Steam Sterilization

[00842078130919]

Moist Heat or Steam Sterilization

[00842078130919]

Moist Heat or Steam Sterilization

[00842078130919]

Moist Heat or Steam Sterilization

[00842078130919]

Moist Heat or Steam Sterilization

[00842078130919]

Moist Heat or Steam Sterilization

[00842078130919]

Moist Heat or Steam Sterilization

[00842078130919]

Moist Heat or Steam Sterilization

[00842078130919]

Moist Heat or Steam Sterilization

[00842078130919]

Moist Heat or Steam Sterilization

[00842078130919]

Moist Heat or Steam Sterilization

[00842078130919]

Moist Heat or Steam Sterilization

[00842078130919]

Moist Heat or Steam Sterilization

[00842078130919]

Moist Heat or Steam Sterilization

[00842078130919]

Moist Heat or Steam Sterilization

[00842078130919]

Moist Heat or Steam Sterilization

[00842078130919]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-07-26
• Device Publish Date: 2024-07-18

On-Brand Devices [Omni Lapidus Plating]

• 00842078133972: SlotLock Lapidus Plate Caddy
• 00842078130957: SlotLock Lapidus Plate, Straight, 4-Hole
• 00842078130940: SlotLock Lapidus Plate, 6-Hole, Right
• 00842078130933: SlotLock Lapidus Plate, 6-Hole, Left
• 00842078130926: SlotLock Lapidus Plate, Slim, 4-Hole
• 00842078130919: SlotLock Lapidus Plate, 5-Hole, Right
• 00842078130902: SlotLock Lapidus Plate, 5-Hole, Left