DELTA XTEND 130720101

GUDID 10603295027287

DELTA Xtend Cementless Modular Centered Epiphysis Sz1 / CENT HA

DEPUY FRANCE

Total reverse shoulder prosthesis

• Primary Device ID: 10603295027287
• NIH Device Record Key: 12abbf21-b104-4977-b944-1d2df197198f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DELTA XTEND
• Version Model Number: 130720101
• Catalog Number: 130720101
• 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
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Device Identifiers

Device Issuing Agency	Device ID
GS1	10603295027287 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071379

FDA Product Code

• KWS: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• PHX: shoulder prosthesis, reverse configuration

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: 2020-01-13
• Device Publish Date: 2015-09-24

On-Brand Devices [DELTA XTEND]

• 10603295256625: DELTA Xtend HUMERAL HEAD EXTRACTOR
• 10603295116639: DELTA Xtend PIN EXTRACTOR
• 10603295116363: DELTA Xtend HUMERAL IMPLANT DRIVER
• 10603295116417: DELTA Xtend V SHAPE GLENOID RETRACTOR
• 10603295027737: DELTA Xtend Cementless Metaglene HA
• 10603295027331: DELTA Xtend Cementless Modular Eccentric Epiphysis Sz2 / RIGHT HA
• 10603295027324: DELTA Xtend Cementless Modular Eccentric Epiphysis Sz2 / LEFT HA
• 10603295027317: DELTA Xtend Cementless Modular Centered Epiphysis Sz2 / CENT HA
• 10603295027300: DELTA Xtend Cementless Modular Eccentric Epiphysis Sz1 / RIGHT HA
• 10603295027294: DELTA Xtend Cementless Modular Eccentric Epiphysis Sz1 / LEFT HA
• 10603295027287: DELTA Xtend Cementless Modular Centered Epiphysis Sz1 / CENT HA
• 10603295027270: DELTA Xtend Cementless Modular Humeral Stem Dia 16 HA
• 10603295027225: DELTA Xtend Cementless Modular Humeral Stem Dia 14 HA
• 10603295027171: DELTA Xtend Cementless Modular Humeral Stem Dia 12 HA
• 10603295027126: DELTA Xtend Cementless Modular Humeral Stem Dia 10 HA
• 10603295272915: DELTA XTEND REVERSE SHOULDER SYSTEM Cementless Metaglene +15mm HA COATED CEMENTLESS
• 10603295272908: DELTA XTEND REVERSE SHOULDER SYSTEM Cementless Metaglene +10mm HA COATED CEMENTLESS
• 10603295116615: DELTA Xtend CUP EXTRACTION CLAMP