Patellar Component 61125PF

GUDID EPIS61125PF0

Episurf Operations AB

Partial-resurfacing patella prosthesis

• Primary Device ID: EPIS61125PF0
• NIH Device Record Key: a291e6e6-ef44-442f-94aa-2761997e4725
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Patellar Component
• Version Model Number: D25
• Catalog Number: 61125PF
• Company DUNS: 352393402
• Company Name: Episurf Operations AB
• 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: true
• Manufacturing Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EPIS61125PF0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221048

FDA Product Code

• KRR: Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-01
• Device Publish Date: 2023-07-24

On-Brand Devices [Patellar Component]

• EPIS61125PF0: D25
• EPIS61120PF0: D20