implaFit® hip stem with collar cemented standard

GUDID 04048844477332

implantcast GmbH

Coated femoral stem prosthesis, one-piece

• Primary Device ID: 04048844477332
• NIH Device Record Key: b6dab248-ff77-4a89-84c5-41e3d8fe7225
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: implaFit® hip stem with collar cemented standard
• Version Model Number: 80080005
• Company DUNS: 324369826
• Company Name: implantcast GmbH
• 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

Device Dimensions

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Device Identifiers

Device Issuing Agency	Device ID
GS1	04048844477332 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210678

FDA Product Code

• LZO: Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

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: 2022-08-29
• Device Publish Date: 2022-08-20

On-Brand Devices [implaFit® hip stem with collar cemented standard]

• 04048844477363: 80080008
• 04048844477356: 80080007
• 04048844477349: 80080006
• 04048844477332: 80080005
• 04048844477325: 80080004
• 04048844477318: 80080003
• 04048844477301: 80080002