ALPHALOK Plating System TLP-SYNS-F

GUDID 00841731133915

ANKLE FX Syndesmosis Fusion Plate

VILEX LLC

Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable Orthopaedic fixation plate, non-bioabsorbable

• Primary Device ID: 00841731133915
• NIH Device Record Key: c68a8478-0d1d-4a5e-b82e-b2514e4354f3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ALPHALOK Plating System
• Version Model Number: TLP-SYNS-F
• Catalog Number: TLP-SYNS-F
• 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	00841731133915 [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

[00841731133915]

Moist Heat or Steam Sterilization

[00841731133915]

Moist Heat or Steam Sterilization

[00841731133915]

Moist Heat or Steam Sterilization

[00841731133915]

Moist Heat or Steam Sterilization

[00841731133915]

Moist Heat or Steam Sterilization

[00841731133915]

Moist Heat or Steam Sterilization

[00841731133915]

Moist Heat or Steam Sterilization

[00841731133915]

Moist Heat or Steam Sterilization

[00841731133915]

Moist Heat or Steam Sterilization

[00841731133915]

Moist Heat or Steam Sterilization

[00841731133915]

Moist Heat or Steam Sterilization

[00841731133915]

Moist Heat or Steam Sterilization

[00841731133915]

Moist Heat or Steam Sterilization

[00841731133915]

Moist Heat or Steam Sterilization

[00841731133915]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-02-20
• Device Publish Date: 2024-02-12

On-Brand Devices [ALPHALOK Plating System]

• 00841731128904: RECON Fibula Plate, Medium, Right 10 Holes
• 00841731128898: RECON Fibula Plate, Medium, Left 10 Holes
• 00841731128881: RECON Fibula Plate, Small, Right 9 Holes
• 00841731128874: RECON Fibula Plate, Small, Left 9 Holes
• 00841731128867: RECON Fibula Plate, X-Small, Right 8 Holes
• 00841731128850: RECON Fibula Plate, X-Small, Left 8 Holes
• 00841731128843: RECON Straight Fibula Plate - 10 Holes
• 00841731128836: RECON Straight Fibula Plate - 9 Holes
• 00841731128829: RECON Straight Fibula Plate - 8 Holes
• 00841731128812: RECON Straight Fibula Plate - 7 Holes
• 00841731128805: RECON Straight Fibula Plate - 6 Holes
• 00841731128799: RECON Straight Fibula Plate - 5 Holes
• 00841731128782: RECON Tarantula Plate Washer, 15mm
• 00841731128775: RECON Tarantula Plate Washer, 12.5mm
• 00841731128768: RECON Tarantula Plate Washer, 10mm
• 00841731128751: RECON Tarantula Plate Washer, 8mm
• 00841731128744: RECON MTP Plate Revision, 62mm Right
• 00841731128737: RECON MTP Plate Revision, 62mm Left
• 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
• 00841731128423: RECON NC Plate, 28mm
• 00841731128416: RECON Medial Column, 85mm Right