04124416S

GUDID H67904124416S0

4.5MM TI VA-LCP CRVD CONDYLAR PLATE/16H/336MM/RT-STER

SYNTHES (U.S.A.) LP

Orthopaedic fixation plate, non-bioabsorbable, sterile

• Primary Device ID: H67904124416S0
• NIH Device Record Key: 0d1f4657-8815-45d5-8567-1e898f45caea
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 04.124.416S
• Catalog Number: 04124416S
• Company DUNS: 832637081
• Company Name: SYNTHES (U.S.A.) LP
• 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: 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

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Device Identifiers

Device Issuing Agency	Device ID
GS1	10886982111050 [Primary]
HIBCC	H67904124416S0 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110354

FDA Product Code

• JDP: condylar plate fixation Implant

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-10-29
• Device Publish Date: 2019-10-21

Devices Manufactured by SYNTHES (U.S.A.) LP

• 10886982297280 - NA: 2024-09-11 SCHANZ PIN REMOVAL TOOL
• H9814871830 - Click'X: 2024-09-11 7.0MM TI CLICK'X® MONOAXIAL PEDICLE SCREW 90MM THRD LENGTH
• H9812982060 - NA: 2024-07-24 ANGLED LAMINA HOOK/ DUAL-OPENING SIDE
• H6792042280 - NA: 2024-07-24 3.5MM SHAFT SCREW 28MM
• H6792042320 - NA: 2024-07-24 3.5MM SHAFT SCREW 32MM
• H6792042340 - NA: 2024-07-24 3.5MM SHAFT SCREW 34MM
• H6792042360 - NA: 2024-07-24 3.5MM SHAFT SCREW 36MM
• H6792042380 - NA: 2024-07-24 3.5MM SHAFT SCREW 38MM