Tibial insert, PS 2303-3067

GUDID 04711605575393

Tibial insert, PS, #6, 12mm

UNITED ORTHOPEDIC CORP.

Cruciate-retaining total knee prosthesis

• Primary Device ID: 04711605575393
• NIH Device Record Key: ec081ae3-aaef-4492-9e6f-cdff0e6c0f2a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tibial insert, PS
• Version Model Number: 2303-3067
• Catalog Number: 2303-3067
• 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

• Height: 12 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	04711605575393 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150829

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: 2018-07-26
• Device Publish Date: 2015-12-04

On-Brand Devices [Tibial insert, PS]

• 04712771505481: Tibial insert, PS, #7, 18mm
• 04712771505474: Tibial insert, PS, #7, 15mm
• 04712771505467: Tibial insert, PS, #7, 13mm
• 04712771505450: Tibial insert, PS, #7, 11mm
• 04712771505443: Tibial insert, PS, #7, 9mm
• 04711605575478: Tibial insert, PS, #7, 17mm
• 04711605575461: Tibial insert, PS, #7, 16mm
• 04711605575454: Tibial insert, PS, #7, 14mm
• 04711605575447: Tibial insert, PS, #7, 12mm
• 04711605575430: Tibial insert, PS, #7, 10mm
• 04711605575423: Tibial insert, PS, #6, 17mm
• 04711605575416: Tibial insert, PS, #6, 16mm
• 04711605575409: Tibial insert, PS, #6, 14mm
• 04711605575393: Tibial insert, PS, #6, 12mm
• 04711605575386: Tibial insert, PS, #6, 10mm
• 04711605575379: Tibial insert, PS, #5, 17mm
• 04711605575362: Tibial insert, PS, #5, 16mm
• 04711605575355: Tibial insert, PS, #5, 14mm
• 04711605575348: Tibial insert, PS, #5, 12mm
• 04711605575331: Tibial insert, PS, #5, 10mm
• 04711605575324: Tibial insert, PS, #4, 17mm
• 04711605575317: Tibial insert, PS, #4, 16mm
• 04711605575300: Tibial insert, PS, #4, 14mm
• 04711605575294: Tibial insert, PS, #4, 12mm
• 04711605575287: Tibial insert, PS, #4, 10mm
• 04711605575270: Tibial insert, PS, #3, 17mm
• 04711605575263: Tibial insert, PS, #3, 16mm
• 04711605575256: Tibial insert, PS, #3, 14mm
• 04711605575249: Tibial insert, PS, #3, 12mm
• 04711605575232: Tibial insert, PS, #3, 10mm
• 04711605575225: Tibial insert, PS, #2, 17mm
• 04711605575218: Tibial insert, PS, #2, 16mm
• 04711605575201: Tibial insert, PS, #2, 14mm
• 04711605575195: Tibial insert, PS, #2, 12mm
• 04711605575188: Tibial insert, PS, #2, 10mm
• 04711605575171: Tibial insert, PS, #1, 17mm
• 04711605575164: Tibial insert, PS, #1, 16mm
• 04711605575157: Tibial insert, PS, #1, 14mm
• 04711605575140: Tibial insert, PS, #1, 12mm
• 04711605575133: Tibial insert, PS, #1, 10mm