implaFit® hip stem with collar cemented lateralized

GUDID 04048844477417

implantcast GmbH

Coated femoral stem prosthesis, one-piece

• Primary Device ID: 04048844477417
• NIH Device Record Key: 1ffc01af-300d-4d70-ba40-dd1b36281c8a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: implaFit® hip stem with collar cemented lateralized
• Version Model Number: 80081003
• 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	04048844477417 [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 lateralized]

• 04048844477462: 80081008
• 04048844477455: 80081007
• 04048844477448: 80081006
• 04048844477431: 80081005
• 04048844477424: 80081004
• 04048844477417: 80081003
• 04048844477400: 80081002