Tibial Baseplate, PSA type 2203-5010

GUDID 04712602346085

Tibial Baseplate, PSA type, #1

UNITED ORTHOPEDIC CORP.

Cruciate-retaining total knee prosthesis

• Primary Device ID: 04712602346085
• NIH Device Record Key: e35c8560-1e48-4aef-948a-54cd46152822
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tibial Baseplate, PSA type
• Version Model Number: 2203-5010
• Catalog Number: 2203-5010
• 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	04712602346085 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082424

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: 2018-07-18
• Device Publish Date: 2015-10-24

On-Brand Devices [Tibial Baseplate, PSA type]

• 04712602346139: Tibial Baseplate, PSA type, #6
• 04712602346122: Tibial Baseplate, PSA type, #5
• 04712602346115: Tibial Baseplate, PSA type, #4
• 04712602346108: Tibial Baseplate, PSA type, #3
• 04712602346092: Tibial Baseplate, PSA type, #2
• 04712602346085: Tibial Baseplate, PSA type, #1