AMIStem C Femoral Stems

GUDID 07630030804281

AMIStem C Cemented Stem Standard Size 3

Medacta International SA

Uncoated hip femur prosthesis, one-piece
Primary Device ID07630030804281
NIH Device Record Keyd826cf09-e326-40a3-bcca-2597e01c0620
Commercial Distribution StatusIn Commercial Distribution
Brand NameAMIStem C Femoral Stems
Version Model Number01.18.153
Company DUNS488227125
Company NameMedacta International SA
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

Device Identifiers

Device Issuing AgencyDevice ID
GS107630030804281 [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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2014-11-18

On-Brand Devices [AMIStem C Femoral Stems]

07630030804335AMIStem C Cemented Stem Standard Size 8
07630030804328AMIStem C Cemented Stem Standard Size 7
07630030804311AMIStem C Cemented Stem Standard Size 6
07630030804304AMIStem C Cemented Stem Standard Size 5
07630030804298AMIStem C Cemented Stem Standard Size 4
07630030804281AMIStem C Cemented Stem Standard Size 3
07630030804274AMIStem C Cemented Stem Standard Size 2
07630030804267AMIStem C Cemented Stem Standard Size 1
07630030804250AMIStem C Cemented Stem Standard Size 0
07630030803864AMIStem C Cemented Stem Lateralized Size 8
07630030803857AMIStem C Cemented Stem Lateralized Size 7
07630030803840AMIStem C Cemented Stem Lateralized Size 6
07630030803833AMIStem C Cemented Stem Lateralized Size 5
07630030803826AMIStem C Cemented Stem Lateralized Size 4
07630030803819AMIStem C Cemented Stem Lateralized Size 3
07630030803802AMIStem C Cemented Stem Lateralized Size 2
07630030803796AMIStem C Cemented Stem Lateralized Size 1
07630030803789AMIStem C Cemented Stem Lateralized Size 0
07630971212541AMIStem-C Std. Cemented Femoral stem size 00

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