ALPHALOK Plating System TLP75-11AL

GUDID 00841731131201

ANKLE FX Anterior Lateral Plate - Left, 75mm

VILEX LLC

Orthopaedic fixation plate, non-bioabsorbable, non-sterile

• Primary Device ID: 00841731131201
• NIH Device Record Key: ada1581c-ad8b-4cd6-adf3-b94199e3bb55
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ALPHALOK Plating System
• Version Model Number: TLP75-11AL
• Catalog Number: TLP75-11AL
• Company DUNS: 117502293
• Company Name: VILEX 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841731131201 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230204

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

[00841731131201]

Moist Heat or Steam Sterilization

[00841731131201]

Moist Heat or Steam Sterilization

[00841731131201]

Moist Heat or Steam Sterilization

[00841731131201]

Moist Heat or Steam Sterilization

[00841731131201]

Moist Heat or Steam Sterilization

[00841731131201]

Moist Heat or Steam Sterilization

[00841731131201]

Moist Heat or Steam Sterilization

[00841731131201]

Moist Heat or Steam Sterilization

[00841731131201]

Moist Heat or Steam Sterilization

[00841731131201]

Moist Heat or Steam Sterilization

[00841731131201]

Moist Heat or Steam Sterilization

[00841731131201]

Moist Heat or Steam Sterilization

[00841731131201]

Moist Heat or Steam Sterilization

[00841731131201]

Moist Heat or Steam Sterilization

[00841731131201]

Moist Heat or Steam Sterilization

[00841731131201]

Moist Heat or Steam Sterilization

[00841731131201]

Moist Heat or Steam Sterilization

[00841731131201]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-21
• Device Publish Date: 2023-08-11

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• 00841731128843: RECON Straight Fibula Plate - 10 Holes
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• 00841731128782: RECON Tarantula Plate Washer, 15mm
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• 00841731128744: RECON MTP Plate Revision, 62mm Right
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• 00841731128720: RECON MTP Plate, 48mm Straight Right
• 00841731128713: RECON MTP Plate Large 10D, 53mm Right
• 00841731128706: RECON MTP Plate, 48mm Straight Left
• 00841731128690: RECON MTP Plate Large 10D, 53mm Left
• 00841731128683: RECON MTP Plate Large 5D, 53mm Right
• 00841731128676: RECON MTP Plate Large 5D, 53mm Left
• 00841731128669: RECON MTP Plate Large 0D, 53mm Right
• 00841731128652: RECON MTP Plate Large 0D, 53mm Left
• 00841731128645: RECON MTP Plate Medium 10D, 45mm Right
• 00841731128638: RECON MTP Plate Medium 10D, 45mm Left
• 00841731128621: RECON MTP Plate Medium 5D, 45mm Right
• 00841731128614: RECON MTP Plate Medium 5D, 45mm Left
• 00841731128607: RECON MTP Plate Medium 0D, 45mm Right
• 00841731128591: RECON MTP Plate Medium 0D, 45mm Left
• 00841731128584: RECON MTP Plate Small 10D, 40mm Right
• 00841731128577: RECON MTP Plate Small 10D, 40mm Left
• 00841731128560: RECON MTP Plate Small 5D, 40mm Right
• 00841731128553: RECON MTP Plate Small 5D, 40mm Left
• 00841731128546: RECON MTP Plate Small 0D, 40mm Right
• 00841731128539: RECON MTP Plate Small 0D, 40mm Left
• 00841731128522: RECON Universal Plate, 61mm Right
• 00841731128515: RECON Universal Plate, 61mm Left
• 00841731128508: RECON Universal Plate, 53mm Right
• 00841731128492: RECON Universal Plate, 53mm Left
• 00841731128485: RECON Universal Plate, 39mm Right
• 00841731128478: RECON Universal Plate, 39mm Left
• 00841731128461: RECON Universal Plate, 31mm Right
• 00841731128454: RECON Universal Plate, 31mm Left
• 00841731128447: RECON TN Plate
• 00841731128430: RECON NC Plate, 33mm
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