C-STEM 961308000

GUDID 10603295236764

C-STEM Revision Stem - Length 240mm SIZE 4 9/10 TAPER CEMENTED

DEPUY (IRELAND)

Revision uncoated hip femur prosthesis

• Primary Device ID: 10603295236764
• NIH Device Record Key: f14cc88e-207b-4d82-9bdd-c97713bfe35b
• Commercial Distribution Discontinuation: 2022-07-01
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: C-STEM
• Version Model Number: 9613-08-000
• Catalog Number: 961308000
• Company DUNS: 989365556
• Company Name: DEPUY (IRELAND)
• 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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• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10603295236764 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K982918

FDA Product Code

• JDI: Prosthesis, hip, semi-constrained, metal/polymer, cemented
• LZN: CEMENT OBTURATOR

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: 2022-06-22
• Device Publish Date: 2015-09-24

On-Brand Devices [C-STEM]

• 10603295060369: C-STEM AMT Cemented Stem High Offset Size 8 12/14 TAPER
• 10603295060352: C-STEM AMT Cemented Stem High Offset Size 7 12/14 TAPER
• 10603295060345: C-STEM AMT Cemented Stem High Offset Size 6 12/14 TAPER
• 10603295060338: C-STEM AMT Cemented Stem High Offset Size 5 12/14 TAPER
• 10603295060321: C-STEM AMT Cemented Stem High Offset Size 4 12/14 TAPER
• 10603295060307: C-STEM AMT Cemented Stem High Offset Size 3 12/14 TAPER
• 10603295060291: C-STEM AMT Cemented Stem High Offset Size 2 12/14 TAPER
• 10603295060284: C-STEM AMT Cemented Stem High Offset SIZE 1 12/14 TAPER
• 10603295059677: C-STEM AMT Cemented Stem Standard Offset Size 8 12/14 TAPER
• 10603295059660: C-STEM AMT Cemented Stem Standard Offset Size 7 12/14 TAPER
• 10603295059653: C-STEM AMT Cemented Stem Standard Offset Size 6 12/14 TAPER
• 10603295059646: C-STEM AMT Cemented Stem Standard Offset Size 5 12/14 TAPER
• 10603295059639: C-STEM AMT Cemented Stem Standard Offset Size 4 12/14 TAPER
• 10603295059615: C-STEM AMT Cemented Stem Standard Offset Size 3 12/14 TAPER
• 10603295059608: C-STEM AMT Cemented Stem Standard Offset Size 2 12/14 TAPER
• 10603295059592: C-STEM AMT Cemented Stem Standard Offset SIZE 1 12/14 TAPER
• 10603295236849: C-STEM Stem High Offset SIZE 2 9/10 TAPER CEMENTED
• 10603295236801: C-STEM Revision Stem - Length 240mm SIZE 8 9/10 TAPER CEMENTED
• 10603295236795: C-STEM Revision Stem - Length 200mm SIZE 8 9/10 TAPER CEMENTED
• 10603295236788: C-STEM Revision Stem - Length 240mm SIZE 6 9/10 TAPER CEMENTED
• 10603295236771: C-STEM Revision Stem - Length 200mm SIZE 6 9/10 TAPER CEMENTED
• 10603295236764: C-STEM Revision Stem - Length 240mm SIZE 4 9/10 TAPER CEMENTED
• 10603295236757: C-STEM Revision Stem - Length 200mm SIZE 4 9/10 TAPER CEMENTED
• 10603295235286: C-STEM Stem High Offset SIZE 5 9/10 TAPER CEMENTED
• 10603295235279: C-STEM Stem High Offset SIZE 4 9/10 TAPER CEMENTED
• 10603295235262: C-STEM Stem High Offset SIZE 3 9/10 TAPER CEMENTED
• 10603295235255: C-STEM Stem SIZE 8 9/10 TAPER CEMENTED
• 10603295235248: C-STEM Stem SIZE 7 9/10 TAPER CEMENTED
• 10603295235231: C-STEM Stem SIZE 6 9/10 TAPER CEMENTED
• 10603295235224: C-STEM Stem SIZE 5 9/10 TAPER CEMENTED
• 10603295235217: C-STEM Stem SIZE 4 9/10 TAPER CEMENTED
• 10603295235200: C-STEM Stem SIZE 3 9/10 TAPER CEMENTED
• 10603295235194: C-STEM Stem SIZE 2 9/10 TAPER CEMENTED
• 10603295235187: C-STEM Stem SIZE 1 9/10 TAPER CEMENTED
• 10603295235170: C-STEM Stem SIZE CDH 9/10 TAPER CEMENTED