All poly tibial component, CR 2203-1059

GUDID 04711605577229

All poly tibial component, CR, #5, 16mm

UNITED ORTHOPEDIC CORP.

Cruciate-retaining total knee prosthesis

• Primary Device ID: 04711605577229
• NIH Device Record Key: d1a40865-ad9a-4a54-9a17-fe6cec637f62
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: All poly tibial component, CR
• Version Model Number: 2203-1059
• Catalog Number: 2203-1059
• Company DUNS: 656700556
• Company Name: UNITED ORTHOPEDIC CORP.
• 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: +886229294567
• Email: service@uoc.com.tw

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	04711605577229 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152430

FDA Product Code

• JWH: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

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: 2018-07-30
• Device Publish Date: 2016-05-02

On-Brand Devices [All poly tibial component, CR]

• 04711605577434: All poly tibial component, CR, #7, 17mm
• 04711605577427: All poly tibial component, CR, #7, 16mm
• 04711605577410: All poly tibial component, CR, #7, 14mm
• 04711605577403: All poly tibial component, CR, #7, 12mm
• 04711605577397: All poly tibial component, CR, #7, 10mm
• 04711605577380: All poly tibial component, CR, #7, 18mm
• 04711605577373: All poly tibial component, CR, #7, 15mm
• 04711605577366: All poly tibial component, CR, #7, 13mm
• 04711605577359: All poly tibial component, CR, #7, 11mm
• 04711605577342: All poly tibial component, CR, #7, 9mm
• 04711605577335: All poly tibial component, CR, #6, 17mm
• 04711605577328: All poly tibial component, CR, #6, 16mm
• 04711605577311: All poly tibial component, CR, #6, 14mm
• 04711605577304: All poly tibial component, CR, #6, 12mm
• 04711605577298: All poly tibial component, CR, #6, 10mm
• 04711605577281: All poly tibial component, CR, #6, 18mm
• 04711605577274: All poly tibial component, CR, #6, 15mm
• 04711605577267: All poly tibial component, CR, #6, 13mm
• 04711605577250: All poly tibial component, CR, #6, 11mm
• 04711605577243: All poly tibial component, CR, #6, 9mm
• 04711605577236: All poly tibial component, CR, #5, 17mm
• 04711605577229: All poly tibial component, CR, #5, 16mm
• 04711605577212: All poly tibial component, CR, #5, 14mm
• 04711605577205: All poly tibial component, CR, #5, 12mm
• 04711605577199: All poly tibial component, CR, #5, 10mm
• 04711605577182: All poly tibial component, CR, #5, 18mm
• 04711605577175: All poly tibial component, CR, #5, 15mm
• 04711605577168: All poly tibial component, CR, #5, 13mm
• 04711605577151: All poly tibial component, CR, #5, 11mm
• 04711605577144: All poly tibial component, CR, #5, 9mm
• 04711605577137: All poly tibial component, CR, #4, 17mm
• 04711605577120: All poly tibial component, CR, #4, 16mm
• 04711605577113: All poly tibial component, CR, #4, 14mm
• 04711605577106: All poly tibial component, CR, #4, 12mm
• 04711605577090: All poly tibial component, CR, #4, 10mm
• 04711605577083: All poly tibial component, CR, #4, 18mm
• 04711605577076: All poly tibial component, CR, #4, 15mm
• 04711605577069: All poly tibial component, CR, #4, 13mm
• 04711605577052: All poly tibial component, CR, #4, 11mm
• 04711605577045: All poly tibial component, CR, #4, 9mm
• 04711605577038: All poly tibial component, CR, #3, 17mm
• 04711605577021: All poly tibial component, CR, #3, 16mm
• 04711605577014: All poly tibial component, CR, #3, 14mm
• 04711605577007: All poly tibial component, CR, #3, 12mm
• 04711605576994: All poly tibial component, CR, #3, 10mm
• 04711605576987: All poly tibial component, CR, #3, 18mm
• 04711605576970: All poly tibial component, CR, #3, 15mm
• 04711605576963: All poly tibial component, CR, #3, 13mm
• 04711605576956: All poly tibial component, CR, #3, 11mm
• 04711605576949: All poly tibial component, CR, #3, 9mm