KANEDA SR 32101525C

GUDID 10705034241319

KANEDA SR ANTERIOR SYSTEM SMALL PLATE, CAUDAL 15 x 26mm

DEPUY SPINE, LLC

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 10705034241319
• NIH Device Record Key: bfe20c74-b44a-4c78-b6f4-ab390aca4e3d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KANEDA SR
• Version Model Number: 32101525C
• Catalog Number: 32101525C
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705034241319 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K971248

FDA Product Code

• KWQ: Appliance, fixation, spinal intervertebral body

Sterilization

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

[10705034241319]

Moist Heat or Steam Sterilization

[10705034241319]

Moist Heat or Steam Sterilization

[10705034241319]

Moist Heat or Steam Sterilization

[10705034241319]

Moist Heat or Steam Sterilization

[10705034241319]

Moist Heat or Steam Sterilization

[10705034241319]

Moist Heat or Steam Sterilization

[10705034241319]

Moist Heat or Steam Sterilization

[10705034241319]

Moist Heat or Steam Sterilization

[10705034241319]

Moist Heat or Steam Sterilization

[10705034241319]

Moist Heat or Steam Sterilization

[10705034241319]

Moist Heat or Steam Sterilization

[10705034241319]

Moist Heat or Steam Sterilization

[10705034241319]

Moist Heat or Steam Sterilization

[10705034241319]

Moist Heat or Steam Sterilization

[10705034241319]

Moist Heat or Steam Sterilization

[10705034241319]

Moist Heat or Steam Sterilization

[10705034241319]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-07-29
• Device Publish Date: 2024-07-19

On-Brand Devices [KANEDA SR]

• 10705034005195: KANEDA SR ANTERIOR SYSTEM STAPLE TROCHAR ASSEMBLY
• 10705034241319: KANEDA SR ANTERIOR SYSTEM SMALL PLATE, CAUDAL 15 x 26mm