implaFit® hip stem cementless standard

GUDID 04048844477158

implantcast GmbH

Coated femoral stem prosthesis, one-piece
Primary Device ID04048844477158
NIH Device Record Keyd78c752a-06d4-42c8-8421-76d93e0aa5c1
Commercial Distribution StatusIn Commercial Distribution
Brand NameimplaFit® hip stem cementless standard
Version Model Number80030006
Company DUNS324369826
Company Nameimplantcast GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

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Device Identifiers

Device Issuing AgencyDevice ID
GS104048844477158 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

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

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-08-29
Device Publish Date2022-08-19

On-Brand Devices [implaFit® hip stem cementless standard]

0404884447719680030010
0404884447718980030009
0404884447717280030008
0404884447716580030007
0404884447715880030006
0404884447714180030005
0404884447713480030004
0404884447712780030003
0404884447711080030002
0404884447708080030001

Trademark Results [implaFit]

Mark Image

Registration | Serial
Company
Trademark
Application Date
IMPLAFIT
IMPLAFIT
88302985 not registered Live/Pending
implantcast GmbH
2019-02-15

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