KAR L92526

GUDID 10603295260660

KAR Cementless Revision Femoral Stem with Collar KAR 16 12/14mm

DEPUY FRANCE

Revision coated hip femur prosthesis Revision coated hip femur prosthesis Revision coated hip femur prosthesis Revision coated hip femur prosthesis Revision coated hip femur prosthesis Revision coated hip femur prosthesis Revision coated hip femur prosthesis Revision coated hip femur prosthesis Revision coated hip femur prosthesis

• Primary Device ID: 10603295260660
• NIH Device Record Key: cabd84a2-85af-4f66-9c77-2cebbbed4b82
• Commercial Distribution Discontinuation: 2021-10-22
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: KAR
• Version Model Number: L92526
• Catalog Number: L92526
• Company DUNS: 502491434
• Company Name: DEPUY FRANCE
• 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

• 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	10603295260660 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K961732

FDA Product Code

• LZO: Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented

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: 2021-10-25
• Device Publish Date: 2021-10-15

On-Brand Devices [KAR]

• 10603295260684: KAR Cementless Revision Femoral Stem with Collar KAR 20 12/14mm
• 10603295260677: KAR Cementless Revision Femoral Stem with Collar KAR 18 12/14mm
• 10603295260660: KAR Cementless Revision Femoral Stem with Collar KAR 16 12/14mm