UKNEE Femoral component,non-porous coated 2101-1130-B

GUDID 04712602345187

UKNEE Femoral component,non-porous coated,#3,medium,left

UNITED ORTHOPEDIC CORP.

Cruciate-retaining total knee prosthesis

• Primary Device ID: 04712602345187
• NIH Device Record Key: f797e2c5-271e-41f5-9656-927ebc8b01b9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UKNEE Femoral component,non-porous coated
• Version Model Number: 2101-1130-B
• Catalog Number: 2101-1130-B
• 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	04712602345187 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K021657

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: 2018-07-11
• Device Publish Date: 2015-10-24

On-Brand Devices [UKNEE Femoral component,non-porous coated]

• 04712602345255: UKNEE Femoral component,non-porous coated,#5,X-large,right
• 04712602345248: UKNEE Femoral component,non-porous coated,#4,large,right
• 04712602345231: UKNEE Femoral component,non-porous coated,#3,medium,right
• 04712602345224: UKNEE Femoral component,non-porous coated,#2,small,right
• 04712602345217: UKNEE Femoral component,non-porous coated,#1,X-small,right
• 04712602345200: UKNEE Femoral component,non-porous coated,#5,X-large,left
• 04712602345194: UKNEE Femoral component,non-porous coated,#4,large,left
• 04712602345187: UKNEE Femoral component,non-porous coated,#3,medium,left
• 04712602345170: UKNEE Femoral component,non-porous coated,#2,small,left
• 04712602345163: UKNEE Femoral component,non-porous coated,#1,X-small,left