AlignX

GUDID 00842078110447

Anterior Ankle Fusion Plate, Standard, Left

EXTREMITY MEDICAL, LLC

Orthopaedic fixation plate, non-bioabsorbable, non-sterile

• Primary Device ID: 00842078110447
• NIH Device Record Key: af53df34-db79-41e9-b156-21d0b5a3578c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AlignX
• Version Model Number: 136-10031
• 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: 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	00842078110447 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181067

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

[00842078110447]

Moist Heat or Steam Sterilization

[00842078110447]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-11-05
• Device Publish Date: 2018-10-03

On-Brand Devices [AlignX]

• 00842078116395: Locking Screw - 5.0 x 28mm
• 00842078116388: Locking Screw - 5.0 x 26mm
• 00842078116371: Locking Screw - 5.0 x 24mm
• 00842078116364: Locking Screw - 5.0 x 22mm
• 00842078116357: Non-Locking Screw - 5.0 x 28 mm
• 00842078116340: Non-Locking Screw - 5.0 x 26 mm
• 00842078116333: Non-Locking Screw - 5.0 x 24 mm
• 00842078116326: Non-Locking Screw - 5.0 x 22 mm
• 00842078116319: Locking Screw - 4.0 x 60 mm
• 00842078116302: Locking Screw - 4.0 x 55 mm
• 00842078116296: Locking Screw - 4.0 x 50 mm
• 00842078116289: Non-Locking Screw - 4.0 x 60 mm
• 00842078116272: Non-Locking Screw - 4.0 x 55 mm
• 00842078116265: Non-Locking Screw - 4.0 x 50 mm
• 00842078116258: Lateral Ankle Fusion Plate, TTC, Right
• 00842078116241: Lateral Ankle Fusion Plate, TTC, Left
• 00842078116234: Lateral Ankle Fusion Plate, TT, Right
• 00842078116227: Lateral Ankle Fusion Plate, TT, Left
• 00842078116210: Anterior Ankle Fusion Plate, Standard Narrow, Right
• 00842078116203: Anterior Ankle Fusion Plate, Standard Narrow, Left
• 00842078110973: Locking Screw - 5.0 x 60 mm
• 00842078110966: Locking Screw - 5.0 x 55 mm
• 00842078110959: Locking Screw - 5.0 x 50 mm
• 00842078110942: Locking Screw - 5.0 x 48 mm
• 00842078110935: Locking Screw - 5.0 x 46 mm
• 00842078110928: Locking Screw - 5.0 x 44 mm
• 00842078110911: Locking Screw - 5.0 x 42 mm
• 00842078110904: Locking Screw - 5.0 x 40 mm
• 00842078110898: Locking Screw - 5.0 x 38 mm
• 00842078110881: Locking Screw - 5.0 x 36 mm
• 00842078110874: Locking Screw - 5.0 x 34 mm
• 00842078110867: Locking Screw - 5.0 x 32 mm
• 00842078110850: Locking Screw - 5.0 x 30mm
• 00842078110843: Non-Locking Screw - 5.0 x 60 mm
• 00842078110836: Non-Locking Screw - 5.0 x 55 mm
• 00842078110829: Non-Locking Screw - 5.0 x 50 mm
• 00842078110812: Non-Locking Screw - 5.0 x 48 mm
• 00842078110805: Non-Locking Screw - 5.0 x 46 mm
• 00842078110799: Non-Locking Screw - 5.0 x 44 mm
• 00842078110782: Non-Locking Screw - 5.0 x 42 mm
• 00842078110775: Non-Locking Screw - 5.0 x 40 mm
• 00842078110768: Non-Locking Screw - 5.0 x 38 mm
• 00842078110751: Non-Locking Screw - 5.0 x 36 mm
• 00842078110744: Non-Locking Screw - 5.0 x 34 mm
• 00842078110737: Non-Locking Screw - 5.0 x 32 mm
• 00842078110720: Non-Locking Screw - 5.0 x 30 mm
• 00842078110713: Locking Screw - 4.0 x 45 mm
• 00842078110706: Locking Screw - 4.0 x 40 mm
• 00842078110690: Locking Screw - 4.0 x 38 mm
• 00842078110683: Locking Screw - 4.0 x 36 mm