ACCLAIM 172292000

GUDID 10603295067672

ACCLAIM LINKED BEARING ASSEMBLY

DEPUY ORTHOPAEDICS, INC.

Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis Hinged total elbow prosthesis

• Primary Device ID: 10603295067672
• NIH Device Record Key: 3416197c-ffac-41a9-96f6-c649f466f1b4
• Commercial Distribution Discontinuation: 2022-03-31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACCLAIM
• Version Model Number: 1722-92-000
• Catalog Number: 172292000
• Company DUNS: 080506581
• Company Name: DEPUY ORTHOPAEDICS, INC.
• 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
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• 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	10603295067672 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060696

FDA Product Code

• JDB: PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED
• JDC: PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-03-02
• Device Publish Date: 2015-09-24

On-Brand Devices [ACCLAIM]

• 10603295151852: ACCLAIM PIN SEATING FORCEPS
• 10603295151760: ACCLAIM MALLET
• 10603295151753: ACCLAIM TORQUE LIMITING SCREWDRIVER
• 10603295151494: ACCLAIM UNLINKED ULNAR TRIAL 11mm
• 10603295067672: ACCLAIM LINKED BEARING ASSEMBLY
• 10603295067665: ACCLAIM ELBOW HINGE PIN UNIT
• 10603295067658: ACCLAIM LINKED POLY HUMERAL YOKE