UKNEE Tibial insert, plained 2301-1215

GUDID 04712602346337

UKNEE Tibial insert,plained,medium,15mm

UNITED ORTHOPEDIC CORP.

Cruciate-retaining total knee prosthesis

• Primary Device ID: 04712602346337
• NIH Device Record Key: a6ecb71c-7e37-4bd8-a491-8140aa34f016
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UKNEE Tibial insert, plained
• Version Model Number: 2301-1215
• Catalog Number: 2301-1215
• 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	04712602346337 [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: 2018-07-12
• Device Publish Date: 2015-10-24

On-Brand Devices [UKNEE Tibial insert, plained]

• 04712602346498: UKNEE Tibial insert,plained,XX-large,18mm
• 04712602346481: UKNEE Tibial insert,plained,XX-large,15mm
• 04712602346474: UKNEE Tibial insert,plained,XX-large,13mm
• 04712602346467: UKNEE Tibial insert,plained,XX-large,11mm
• 04712602346450: UKNEE Tibial insert,plained,XX-large,9mm
• 04712602346443: UKNEE Tibial insert,plained,X-large,18mm
• 04712602346436: UKNEE Tibial insert,plained,X-large,15mm
• 04712602346429: UKNEE Tibial insert,plained,X-large,13mm
• 04712602346412: UKNEE Tibial insert,plained,X-large,11mm
• 04712602346405: UKNEE Tibial insert,plained,X-large,9mm
• 04712602346399: UKNEE Tibial insert,plained,large,18mm
• 04712602346382: UKNEE Tibial insert,plained,large,15mm
• 04712602346375: UKNEE Tibial insert,plained,large,13mm
• 04712602346368: UKNEE Tibial insert,plained,large,11mm
• 04712602346351: UKNEE Tibial insert,plained,large,9mm
• 04712602346344: UKNEE Tibial insert,plained,medium,18mm
• 04712602346337: UKNEE Tibial insert,plained,medium,15mm
• 04712602346320: UKNEE Tibial insert,plained,medium,13mm
• 04712602346313: UKNEE Tibial insert,plained,medium,11mm
• 04712602346306: UKNEE Tibial insert,plained,medium,9mm
• 04712602346290: UKNEE Tibial insert,plained,small,18mm
• 04712602346283: UKNEE Tibial insert,plained,small,15mm
• 04712602346276: UKNEE Tibial insert,plained,small,13mm
• 04712602346269: UKNEE Tibial insert,plained,small,11mm
• 04712602346252: UKNEE Tibial insert,plained,small,9mm
• 04712602346245: UKNEE Tibial insert,plained,X-small,18mm
• 04712602346238: UKNEE Tibial insert,plained,X-small,15mm
• 04712602346221: UKNEE Tibial insert,plained,X-small,13mm
• 04712602346214: UKNEE Tibial insert,plained,X-small,11mm
• 04712602346207: UKNEE Tibial insert,plained,X-small,9mm (6+3mm)