Curved stem, PSA type 2703-5137

GUDID 04712771480917

Curved stem, PSA type, Ø21x150mm

UNITED ORTHOPEDIC CORP.

Posterior-stabilized total knee prosthesis

• Primary Device ID: 04712771480917
• NIH Device Record Key: f9b2a672-21d2-4b5e-8f0d-c959aaa1e9a4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Curved stem, PSA type
• Version Model Number: 2703-5137
• Catalog Number: 2703-5137
• 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

• Length: 150 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	04712771480917 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082424

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: 2018-07-24
• Device Publish Date: 2015-10-24

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• 04712771480849: Curved stem, PSA type, Ø11x150mm
• 04712602349475: Curved stem, PSA type, Ø16x150mm
• 04712602349468: Curved stem, PSA type, Ø14x150mm
• 04712602349451: Curved stem, PSA type, Ø12x150mm
• 04712602349444: Curved stem, PSA type, Ø10x150mm