EXPEDIUM TOP NOTCH 189671555

GUDID 10705034178769

EXPEDIUM SPINE SYSTEM SIDE LOADING OPEN/OPEN TOP NOTCH CONNECTOR 6.35 x 5.5mm

DEPUY SPINE, LLC

Bone-screw internal spinal fixation system connector

• Primary Device ID: 10705034178769
• NIH Device Record Key: b856752b-e4b9-4b00-a941-561e109a4d0b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EXPEDIUM TOP NOTCH
• Version Model Number: 189671555
• Catalog Number: 189671555
• Company DUNS: 107105876
• Company Name: DEPUY SPINE, 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705034178769 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092626

FDA Product Code

• MNI: ORTHOSIS, SPINAL PEDICLE FIXATION

Sterilization

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

[10705034178769]

Moist Heat or Steam Sterilization

[10705034178769]

Moist Heat or Steam Sterilization

[10705034178769]

Moist Heat or Steam Sterilization

[10705034178769]

Moist Heat or Steam Sterilization

[10705034178769]

Moist Heat or Steam Sterilization

[10705034178769]

Moist Heat or Steam Sterilization

[10705034178769]

Moist Heat or Steam Sterilization

[10705034178769]

Moist Heat or Steam Sterilization

[10705034178769]

Moist Heat or Steam Sterilization

[10705034178769]

Moist Heat or Steam Sterilization

[10705034178769]

Moist Heat or Steam Sterilization

[10705034178769]

Moist Heat or Steam Sterilization

[10705034178769]

Moist Heat or Steam Sterilization

[10705034178769]

Moist Heat or Steam Sterilization

[10705034178769]

Moist Heat or Steam Sterilization

[10705034178769]

Moist Heat or Steam Sterilization

[10705034178769]

Moist Heat or Steam Sterilization

[10705034178769]

Moist Heat or Steam Sterilization

[10705034178769]

Moist Heat or Steam Sterilization

[10705034178769]

Moist Heat or Steam Sterilization

[10705034178769]

Moist Heat or Steam Sterilization

[10705034178769]

Moist Heat or Steam Sterilization

[10705034178769]

Moist Heat or Steam Sterilization

[10705034178769]

Moist Heat or Steam Sterilization

[10705034178769]

Moist Heat or Steam Sterilization

[10705034178769]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2024-07-23
• Device Publish Date: 2015-09-24

On-Brand Devices [EXPEDIUM TOP NOTCH]

• 10705034200859: EXPEDIUM SPINE SYSTEM HOOK HOLDER FOR TOP NOTCH 6.35
• 10705034200842: EXPEDIUM SPINE SYSTEM OFFSET HOOK HOLDER FOR TOP NOTCH 6.35
• 10705034153131: EXPEDIUM SPINE SYSTEM SIDE LOADING OPEN/OPEN TOP NOTCH CONNECTOR 5.5 x 6.35mm
• 10705034153124: EXPEDIUM SPINE SYSTEM SIDE LOADING OPEN/OPEN TOP NOTCH CONNECTOR 5.5 x 5.5mm
• 10705034178783: EXPEDIUM SPINE SYSTEM SIDE LOADING OPEN/OPEN TOP NOTCH CONNECTOR 6.35 x 6.35mm
• 10705034178769: EXPEDIUM SPINE SYSTEM SIDE LOADING OPEN/OPEN TOP NOTCH CONNECTOR 6.35 x 5.5mm
• 10705034091914: EXPEDIUM SPINE SYSTEM SIDE LOADING OPEN/OPEN TOP NOTCH CONNECTOR 6.35 x 6.35mm
• 10705034091907: EXPEDIUM SPINE SYSTEM SIDE LOADING OPEN/OPEN TOP NOTCH CONNECTOR 6.35 x 5.5mm
• 10705034077826: EXPEDIUM SPINE SYSTEM SIDE LOADING OPEN/OPEN TOP NOTCH CONNECTOR 5.5 x 6.35mm
• 10705034077819: EXPEDIUM SPINE SYSTEM SIDE LOADING OPEN/OPEN TOP NOTCH CONNECTOR 5.5 x 5.5mm