SPS 432162

GUDID 04546540070418

Standard Compression Plate Broad

Stryker Trauma SA

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile

• Primary Device ID: 04546540070418
• NIH Device Record Key: 230a8661-ddb9-4bc4-9615-6390582c605f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SPS
• Version Model Number: 432162
• Catalog Number: 432162
• Company DUNS: 481999654
• Company Name: Stryker Trauma SA
• 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 Dimensions

• Device Size Text, specify: 0
• Length: 220 Millimeter
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Device Identifiers

Device Issuing Agency	Device ID
GS1	04546540070418 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012162

FDA Product Code

• HRS: PLATE, FIXATION, BONE

Sterilization

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

[04546540070418]

Moist Heat or Steam Sterilization

[04546540070418]

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[04546540070418]

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[04546540070418]

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[04546540070418]

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[04546540070418]

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[04546540070418]

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[04546540070418]

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[04546540070418]

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[04546540070418]

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[04546540070418]

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[04546540070418]

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[04546540070418]

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[04546540070418]

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[04546540070418]

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[04546540070418]

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[04546540070418]

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[04546540070418]

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[04546540070418]

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[04546540070418]

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[04546540070418]

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[04546540070418]

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[04546540070418]

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[04546540070418]

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[04546540070418]

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[04546540070418]

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[04546540070418]

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[04546540070418]

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[04546540070418]

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[04546540070418]

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[04546540070418]

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[04546540070418]

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[04546540070418]

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[04546540070418]

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[04546540070418]

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[04546540070418]

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[04546540070418]

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[04546540070418]

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[04546540070418]

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[04546540070418]

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[04546540070418]

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[04546540070418]

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[04546540070418]

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[04546540070418]

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[04546540070418]

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[04546540070418]

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[04546540070418]

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[04546540070418]

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[04546540070418]

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[04546540070418]

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[04546540070418]

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[04546540070418]

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[04546540070418]

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[04546540070418]

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[04546540070418]

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[04546540070418]

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[04546540070418]

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[04546540070418]

Moist Heat or Steam Sterilization

[04546540070418]

Moist Heat or Steam Sterilization

[04546540070418]

Moist Heat or Steam Sterilization

[04546540070418]

Moist Heat or Steam Sterilization

[04546540070418]

Moist Heat or Steam Sterilization

[04546540070418]

Moist Heat or Steam Sterilization

[04546540070418]

Moist Heat or Steam Sterilization

[04546540070418]

Moist Heat or Steam Sterilization

[04546540070418]

Moist Heat or Steam Sterilization

[04546540070418]

Moist Heat or Steam Sterilization

[04546540070418]

Moist Heat or Steam Sterilization

[04546540070418]

Moist Heat or Steam Sterilization

[04546540070418]

Moist Heat or Steam Sterilization

[04546540070418]

Moist Heat or Steam Sterilization

[04546540070418]

Moist Heat or Steam Sterilization

[04546540070418]

Moist Heat or Steam Sterilization

[04546540070418]

Moist Heat or Steam Sterilization

[04546540070418]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-05
• Device Publish Date: 2015-09-24

On-Brand Devices [SPS]

• 07613153051909: Calcaneal Plate
• 07613153051848: Waisted Compression Plate
• 07613153051831: T-Buttress Plate
• 04546540500557: Distal Fibula Plate
• 04546540500540: Distal Fibula Plate
• 04546540500533: Distal Fibula Plate
• 04546540500526: Distal Fibula Plate
• 04546540500519: Distal Fibula Plate
• 04546540500502: Distal Fibula Plate
• 04546540500496: Distal Fibula Plate
• 04546540419415: One-Third Tubular Plate; with Collar
• 04546540373366: Cloverleaf Plate
• 04546540373359: Cloverleaf Plate
• 04546540368904: Calcaneal Plate
• 04546540368898: Calcaneal Plate
• 04546540368881: Calcaneal Plate
• 04546540368874: Calcaneal Plate
• 04546540368867: Cloverleaf Plate
• 04546540368850: Cloverleaf Plate
• 04546540368843: Cloverleaf Plate
• 04546540368836: Cloverleaf Plate
• 04546540368829: Cloverleaf Plate
• 04546540368812: Cloverleaf Plate
• 04546540368805: T-Plate
• 04546540368799: T-Plate
• 04546540368782: T-Plate
• 04546540368775: T-Plate
• 04546540368768: T-Plate
• 04546540368751: T-Plate
• 04546540368744: T-Plate
• 04546540368737: T-Plate
• 04546540368720: T-Plate; oblique angled
• 04546540368713: T-Plate; oblique angled
• 04546540368706: T-Plate; oblique angled
• 04546540368690: T-Plate; oblique angled
• 04546540368683: T-Plate; oblique angled
• 04546540368676: One-Third Tubular Plate; with Collar
• 04546540368669: One-Third Tubular Plate; with Collar
• 04546540368652: One-Third Tubular Plate; with Collar
• 04546540368645: One-Third Tubular Plate; with Collar
• 04546540368638: One-Third Tubular Plate; with Collar
• 04546540368621: One-Third Tubular Plate; with Collar
• 04546540368614: One-Third Tubular Plate; with Collar
• 04546540368607: One-Third Tubular Plate; with Collar
• 04546540368591: One-Third Tubular Plate; with Collar
• 04546540368584: One-Third Tubular Plate; with Collar
• 04546540368577: One-Third Tubular Plate; with Collar
• 04546540368560: One-Third Tubular Plate; with Collar
• 04546540368553: One-Third Tubular Plate; with Collar
• 04546540368546: Reconstruction Plate; straight