XPE Tibial insert, PSA 2303-5633

GUDID 04719872148593

XPE Tibial insert, PSA, #3, 13mm

UNITED ORTHOPEDIC CORP.

Posterior-stabilized total knee prosthesis

• Primary Device ID: 04719872148593
• NIH Device Record Key: 15743d3a-41b5-4ba5-9608-e0c736ac809b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XPE Tibial insert, PSA
• Version Model Number: 2303-5633
• Catalog Number: 2303-5633
• 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	04719872148593 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161360

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: 2018-07-31
• Device Publish Date: 2017-03-16

On-Brand Devices [XPE Tibial insert, PSA]

• 04719872148883: XPE Tibial insert, PSA, #6, 30mm
• 04719872148876: XPE Tibial insert, PSA, #6, 25mm
• 04719872148869: XPE Tibial insert, PSA, #6, 21mm
• 04719872148852: XPE Tibial insert, PSA, #6, 18mm
• 04719872148845: XPE Tibial insert, PSA, #6, 15mm
• 04719872148838: XPE Tibial insert, PSA, #6, 13mm
• 04719872148821: XPE Tibial insert, PSA, #6, 11mm
• 04719872148814: XPE Tibial insert, PSA, #6, 9mm
• 04719872148807: XPE Tibial insert, PSA, #5, 30mm
• 04719872148791: XPE Tibial insert, PSA, #5, 25mm
• 04719872148784: XPE Tibial insert, PSA, #5, 21mm
• 04719872148777: XPE Tibial insert, PSA, #5, 18mm
• 04719872148760: XPE Tibial insert, PSA, #5, 15mm
• 04719872148753: XPE Tibial insert, PSA, #5, 13mm
• 04719872148746: XPE Tibial insert, PSA, #5, 11mm
• 04719872148739: XPE Tibial insert, PSA, #5, 9mm
• 04719872148722: XPE Tibial insert, PSA, #4, 30mm
• 04719872148715: XPE Tibial insert, PSA, #4, 25mm
• 04719872148708: XPE Tibial insert, PSA, #4, 21mm
• 04719872148692: XPE Tibial insert, PSA, #4, 18mm
• 04719872148685: XPE Tibial insert, PSA, #4, 15mm
• 04719872148678: XPE Tibial insert, PSA, #4, 13mm
• 04719872148661: XPE Tibial insert, PSA, #4, 11mm
• 04719872148654: XPE Tibial insert, PSA, #4, 9mm
• 04719872148647: XPE Tibial insert, PSA, #3, 30mm
• 04719872148630: XPE Tibial insert, PSA, #3, 25mm
• 04719872148623: XPE Tibial insert, PSA, #3, 21mm
• 04719872148616: XPE Tibial insert, PSA, #3, 18mm
• 04719872148609: XPE Tibial insert, PSA, #3, 15mm
• 04719872148593: XPE Tibial insert, PSA, #3, 13mm
• 04719872148586: XPE Tibial insert, PSA, #3, 11mm
• 04719872148579: XPE Tibial insert, PSA, #3, 9mm
• 04719872148562: XPE Tibial insert, PSA, #2, 30mm
• 04719872148555: XPE Tibial insert, PSA, #2, 25mm
• 04719872148548: XPE Tibial insert, PSA, #2, 21mm
• 04719872148531: XPE Tibial insert, PSA, #2, 18mm
• 04719872148524: XPE Tibial insert, PSA, #2, 15mm
• 04719872148517: XPE Tibial insert, PSA, #2, 13mm
• 04719872148500: XPE Tibial insert, PSA, #2, 11mm
• 04719872148494: XPE Tibial insert, PSA, #2, 9mm
• 04719872148487: XPE Tibial insert, PSA, #1, 30mm
• 04719872148470: XPE Tibial insert, PSA, #1, 25mm
• 04719872148463: XPE Tibial insert, PSA, #1, 21mm
• 04719872148456: XPE Tibial insert, PSA, #1, 18mm
• 04719872148449: XPE Tibial insert, PSA, #1, 15mm
• 04719872148432: XPE Tibial insert, PSA, #1, 13mm
• 04719872148425: XPE Tibial insert, PSA, #1, 11mm
• 04719872148418: XPE Tibial insert, PSA, #1, 9mm