UKNEE Tibial insert, posterior stabilized 2301-5113

GUDID 04712602346870

UKNEE Tibial insert,posterior stabilized,small,13mm

UNITED ORTHOPEDIC CORP.

Cruciate-retaining total knee prosthesis

• Primary Device ID: 04712602346870
• NIH Device Record Key: 764b8d15-ac4e-4113-8684-d57fce199fab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UKNEE Tibial insert, posterior stabilized
• Version Model Number: 2301-5113
• Catalog Number: 2301-5113
• 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	04712602346870 [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 insert, posterior stabilized]

• 04712602347099: UKNEE Tibial insert,posterior stabilized,XX-large,18mm
• 04712602347082: UKNEE Tibial insert,posterior stabilized,XX-large,15mm
• 04712602347075: UKNEE Tibial insert,posterior stabilized,XX-large,13mm
• 04712602347068: UKNEE Tibial insert,posterior stabilized,XX-large,11mm
• 04712602347051: UKNEE Tibial insert,posterior stabilized,XX-large,9mm
• 04712602347044: UKNEE Tibial insert,posterior stabilized,X-large,18mm
• 04712602347037: UKNEE Tibial insert,posterior stabilized,X-large,15mm
• 04712602347020: UKNEE Tibial insert,posterior stabilized,X-large,13mm
• 04712602347013: UKNEE Tibial insert,posterior stabilized,X-large,11mm
• 04712602347006: UKNEE Tibial insert,posterior stabilized,X-large,9mm
• 04712602346993: UKNEE Tibial insert,posterior stabilized,large,18mm
• 04712602346986: UKNEE Tibial insert,posterior stabilized,large,15mm
• 04712602346979: UKNEE Tibial insert,posterior stabilized,large,13mm
• 04712602346962: UKNEE Tibial insert,posterior stabilized,large,11mm
• 04712602346955: UKNEE Tibial insert,posterior stabilized,large,9mm
• 04712602346948: UKNEE Tibial insert,posterior stabilized,medium,18mm
• 04712602346931: UKNEE Tibial insert,posterior stabilized,medium,15mm
• 04712602346924: UKNEE Tibial insert,posterior stabilized,medium,13mm
• 04712602346917: UKNEE Tibial insert,posterior stabilized,medium,11mm
• 04712602346900: UKNEE Tibial insert,posterior stabilized,medium,9mm
• 04712602346894: UKNEE Tibial insert,posterior stabilized,small,18mm
• 04712602346887: UKNEE Tibial insert,posterior stabilized,small,15mm
• 04712602346870: UKNEE Tibial insert,posterior stabilized,small,13mm
• 04712602346863: UKNEE Tibial insert,posterior stabilized,small,11mm
• 04712602346856: UKNEE Tibial insert,posterior stabilized,small,9mm
• 04712602346849: UKNEE Tibial insert,posterior stabilized,X-small,18mm
• 04712602346832: UKNEE Tibial insert,posterior stabilized,X-small,15mm
• 04712602346825: UKNEE Tibial insert,posterior stabilized,X-small,13mm
• 04712602346818: UKNEE Tibial insert,posterior stabilized,X-small,11mm
• 04712602346801: UKNEE Tibial insert,posterior stabilized,X-small,9mm