02221130S

GUDID 10886982275929

3.5/4.5MM VA PPFX PROX FEMUR PLATE/12HOLES/RIGHT/STERILE

SYNTHES (U.S.A.) LP

Orthopaedic fixation plate, non-bioabsorbable, sterile

• Primary Device ID: 10886982275929
• NIH Device Record Key: d8ccacb5-29f9-4382-9d8c-e0194dd0f2ee
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 02.221.130S
• Catalog Number: 02221130S
• Company DUNS: 832637081
• Company Name: SYNTHES (U.S.A.) LP
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10886982275929 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210205

FDA Product Code

• HRS: Plate, fixation, bone

Sterilization

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

[10886982275929]

Moist Heat or Steam Sterilization

[10886982275929]

Moist Heat or Steam Sterilization

[10886982275929]

Moist Heat or Steam Sterilization

[10886982275929]

Moist Heat or Steam Sterilization

[10886982275929]

Moist Heat or Steam Sterilization

[10886982275929]

Moist Heat or Steam Sterilization

[10886982275929]

Moist Heat or Steam Sterilization

[10886982275929]

Moist Heat or Steam Sterilization

[10886982275929]

Moist Heat or Steam Sterilization

[10886982275929]

Moist Heat or Steam Sterilization

[10886982275929]

Moist Heat or Steam Sterilization

[10886982275929]

Moist Heat or Steam Sterilization

[10886982275929]

Moist Heat or Steam Sterilization

[10886982275929]

Moist Heat or Steam Sterilization

[10886982275929]

Moist Heat or Steam Sterilization

[10886982275929]

Moist Heat or Steam Sterilization

[10886982275929]

Moist Heat or Steam Sterilization

[10886982275929]

Moist Heat or Steam Sterilization

[10886982275929]

Moist Heat or Steam Sterilization

[10886982275929]

Moist Heat or Steam Sterilization

[10886982275929]

Moist Heat or Steam Sterilization

[10886982275929]

Moist Heat or Steam Sterilization

[10886982275929]

Moist Heat or Steam Sterilization

[10886982275929]

Moist Heat or Steam Sterilization

[10886982275929]

Moist Heat or Steam Sterilization

[10886982275929]

Moist Heat or Steam Sterilization

[10886982275929]

Moist Heat or Steam Sterilization

[10886982275929]

Moist Heat or Steam Sterilization

[10886982275929]

Moist Heat or Steam Sterilization

[10886982275929]

Moist Heat or Steam Sterilization

[10886982275929]

Moist Heat or Steam Sterilization

[10886982275929]

Moist Heat or Steam Sterilization

[10886982275929]

Moist Heat or Steam Sterilization

[10886982275929]

Moist Heat or Steam Sterilization

[10886982275929]

Moist Heat or Steam Sterilization

[10886982275929]

Moist Heat or Steam Sterilization

[10886982275929]

Moist Heat or Steam Sterilization

[10886982275929]

Moist Heat or Steam Sterilization

[10886982275929]

Moist Heat or Steam Sterilization

[10886982275929]

Moist Heat or Steam Sterilization

[10886982275929]

Moist Heat or Steam Sterilization

[10886982275929]

Moist Heat or Steam Sterilization

[10886982275929]

Moist Heat or Steam Sterilization

[10886982275929]

Moist Heat or Steam Sterilization

[10886982275929]

Moist Heat or Steam Sterilization

[10886982275929]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-08-19
• Device Publish Date: 2021-08-11

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• 10886982293244 - NA: 2025-02-10 LOCKING SCREW FOR IM NAIL Ø 4MM/ 32MM/ XL25
• 10886982293251 - NA: 2025-02-10 LOCKING SCREW FOR IM NAIL Ø 4MM/ 34MM/ XL25
• 10886982293268 - NA: 2025-02-10 LOCKING SCREW FOR IM NAIL Ø 4MM/ 36MM/ XL25
• 10886982293275 - NA: 2025-02-10 LOCKING SCREW FOR IM NAIL Ø 4MM/ 38MM/ XL25
• 10886982293282 - NA: 2025-02-10 LOCKING SCREW FOR IM NAIL Ø 4MM/ 40MM/ XL25
• 10886982293299 - NA: 2025-02-10 LOCKING SCREW FOR IM NAIL Ø 4MM/ 42MM/ XL25