UKNEE Tibial wedge 2801-1011

GUDID 04712602349482

UKNEE Tibial wedge,#1,X-small,5mm

UNITED ORTHOPEDIC CORP.

Cruciate-retaining total knee prosthesis

• Primary Device ID: 04712602349482
• NIH Device Record Key: 6c5941c6-cc6b-490d-ba06-9f103818bf62
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UKNEE Tibial wedge
• Version Model Number: 2801-1011
• Catalog Number: 2801-1011
• 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	04712602349482 [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: 2018-07-13
• Device Publish Date: 2015-10-24

On-Brand Devices [UKNEE Tibial wedge]

• 04712602349598: UKNEE Tibial wedge,#6,XX-large,10mm
• 04712602349581: UKNEE Tibial wedge,#6,XX-large,5mm
• 04712602349574: UKNEE Tibial wedge,#5,X-large,10mm
• 04712602349567: UKNEE Tibial wedge,#5,X-large,5mm
• 04712602349550: UKNEE Tibial wedge,#4,large,10mm
• 04712602349543: UKNEE Tibial wedge,#4,large,5mm
• 04712602349536: UKNEE Tibial wedge,#3,medium,10mm
• 04712602349529: UKNEE Tibial wedge,#3,medium,5mm
• 04712602349512: UKNEE Tibial wedge,#2,small,10mm
• 04712602349505: UKNEE Tibial wedge,#2,small,5mm
• 04712602349499: UKNEE Tibial wedge,#1,X-small,10mm
• 04712602349482: UKNEE Tibial wedge,#1,X-small,5mm