ACCLAIM 172285000

GUDID 10603295067658

ACCLAIM LINKED POLY HUMERAL YOKE

DEPUY ORTHOPAEDICS, INC.

Hinged total elbow prosthesis

• Primary Device ID: 10603295067658
• NIH Device Record Key: c1cec548-f0ff-4c0c-b3a3-e8f6787a9a54
• Commercial Distribution Discontinuation: 2022-03-31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACCLAIM
• Version Model Number: 1722-85-000
• Catalog Number: 172285000
• 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
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• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10603295067658 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060696

FDA Product Code

• 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