AMIStem C Femoral Stems

GUDID 07630030804311

AMIStem C Cemented Stem Standard Size 6

Medacta International SA

Uncoated hip femur prosthesis, one-piece
Primary Device ID07630030804311
NIH Device Record Key4a579f6c-4f81-422d-8668-51b4687cdd57
Commercial Distribution StatusIn Commercial Distribution
Brand NameAMIStem C Femoral Stems
Version Model Number01.18.156
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
GS107630030804311 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

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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