ANATOMICAL SHOULDER™ REVISION

GUDID 00889024387225

X-piece

Zimmer GmbH

Joint prosthesis implantation kit, reusable Joint prosthesis implantation kit, reusable Joint prosthesis implantation kit, reusable Joint prosthesis implantation kit, reusable Joint prosthesis implantation kit, reusable Joint prosthesis implantation kit, reusable Joint prosthesis implantation kit, reusable Joint prosthesis implantation kit, reusable Joint prosthesis implantation kit, reusable Joint prosthesis implantation kit, reusable Joint prosthesis implantation kit, reusable Joint prosthesis implantation kit, reusable Joint prosthesis implantation kit, reusable Joint prosthesis implantation kit, reusable Joint prosthesis implantation kit, reusable Joint prosthesis implantation kit, reusable Joint prosthesis implantation kit, reusable Joint prosthesis implantation kit, reusable

• Primary Device ID: 00889024387225
• NIH Device Record Key: 429924c2-52b4-4a9d-bfe8-66081b8d7551
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ANATOMICAL SHOULDER™ REVISION
• Version Model Number: 01.04558.302
• Company DUNS: 488133448
• Company Name: Zimmer GmbH
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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)348-2759
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024387225 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142403

FDA Product Code

• KWS: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Sterilization

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

[00889024387225]

Moist Heat or Steam Sterilization

[00889024387225]

Moist Heat or Steam Sterilization

[00889024387225]

Moist Heat or Steam Sterilization

[00889024387225]

Moist Heat or Steam Sterilization

[00889024387225]

Moist Heat or Steam Sterilization

[00889024387225]

Moist Heat or Steam Sterilization

[00889024387225]

Moist Heat or Steam Sterilization

[00889024387225]

Moist Heat or Steam Sterilization

[00889024387225]

Moist Heat or Steam Sterilization

[00889024387225]

Moist Heat or Steam Sterilization

[00889024387225]

Moist Heat or Steam Sterilization

[00889024387225]

Moist Heat or Steam Sterilization

[00889024387225]

Moist Heat or Steam Sterilization

[00889024387225]

Moist Heat or Steam Sterilization

[00889024387225]

Moist Heat or Steam Sterilization

[00889024387225]

Moist Heat or Steam Sterilization

[00889024387225]

Moist Heat or Steam Sterilization

[00889024387225]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-10-14
• Device Publish Date: 2016-09-24

On-Brand Devices [ANATOMICAL SHOULDER™ REVISION]

• 00889024387317: Screw III - Connector II / III
• 00889024387300: Screw II - Connector I
• 00889024387294: Screw I - Connector I
• 00889024387287: Connector III
• 00889024387270: Connector II
• 00889024387263: Connector I
• 00889024387256: Impactor / Extractor humeral stem
• 00889024387225: X-piece
• 00889024387218: Milling cutter
• 00889024387201: Drill