EcoFit® trial cup

GUDID 04048844298357

implantcast GmbH

General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit

Primary Device ID	04048844298357
NIH Device Record Key	9c38239f-f506-43c2-b925-a3bc074eb773
Commercial Distribution Status	In Commercial Distribution
Brand Name	EcoFit® trial cup
Version Model Number	02203066
Company DUNS	324369826
Company Name	implantcast GmbH
Device Count	1
DM Exempt	true
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	false
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

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Device Identifiers

Device Issuing Agency	Device ID
GS1	04048844298357 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K163577

FDA Product Code

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