422397

GUDID H6794223970

5.0MM TI LOCKING SCREW SELF-DRILLING 85MM

Synthes GmbH

Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: H6794223970
• NIH Device Record Key: 7bda15cd-a4b7-41fe-a707-52157f998ea4
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 422.397
• Catalog Number: 422397
• Company DUNS: 486711679
• Company Name: Synthes GmbH
• 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

Customer Support Contacts

• 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
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10886982215918 [Primary]
HIBCC	H6794223970 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K961413

FDA Product Code

• HRS: PLATE, FIXATION, BONE

Sterilization

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

[H6794223970]

Moist Heat or Steam Sterilization

[H6794223970]

Moist Heat or Steam Sterilization

[H6794223970]

Moist Heat or Steam Sterilization

[H6794223970]

Moist Heat or Steam Sterilization

[H6794223970]

Moist Heat or Steam Sterilization

[H6794223970]

Moist Heat or Steam Sterilization

[H6794223970]

Moist Heat or Steam Sterilization

[H6794223970]

Moist Heat or Steam Sterilization

[H6794223970]

Moist Heat or Steam Sterilization

[H6794223970]

Moist Heat or Steam Sterilization

[H6794223970]

Moist Heat or Steam Sterilization

[H6794223970]

Moist Heat or Steam Sterilization

[H6794223970]

Moist Heat or Steam Sterilization

[H6794223970]

Moist Heat or Steam Sterilization

[H6794223970]

Moist Heat or Steam Sterilization

[H6794223970]

Moist Heat or Steam Sterilization

[H6794223970]

Moist Heat or Steam Sterilization

[H6794223970]

Moist Heat or Steam Sterilization

[H6794223970]

Moist Heat or Steam Sterilization

[H6794223970]

Moist Heat or Steam Sterilization

[H6794223970]

Moist Heat or Steam Sterilization

[H6794223970]

Moist Heat or Steam Sterilization

[H6794223970]

Moist Heat or Steam Sterilization

[H6794223970]

Moist Heat or Steam Sterilization

[H6794223970]

Moist Heat or Steam Sterilization

[H6794223970]

Moist Heat or Steam Sterilization

[H6794223970]

Moist Heat or Steam Sterilization

[H6794223970]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-05-02
• Device Publish Date: 2015-09-14

Devices Manufactured by Synthes GmbH

• 07612334260079 - KINCISE: 2024-11-08 KINCISE(TM) SYSTEM SURGICAL HANDPIECE CASE
• 07612334268587 - KINCISE: 2024-11-08 KINCISE(TM) SYSTEM STERILIZATION CASE LID
• 07612334268679 - KINCISE: 2024-11-08 KINCISE(TM) SYSTEM PRIMARY HIP ADAPTER CASE
• 07612334268563 - KINCISE: 2024-11-04 KINCISE™ System Automated Surgical Handpiece V2
• 07612334268570 - KINCISE: 2024-11-04 KINCISE™ System Lithium-ion Battery
• 07612334268594 - KINCISE: 2024-11-04 KINCISE™ System Primary Hip PINNACLE™ Straight Shell/Liner Impactor - Long
• 07612334268600 - KINCISE: 2024-11-04 KINCISE™ System Primary Hip PINNACLE™ Offset Shell/Liner Impactor
• 07612334268617 - KINCISE: 2024-11-04 KINCISE™ System Primary Hip PINNACLE™ Inclination Guide