AMIStem-P

GUDID 07630040720014

AMIStem-P STD stem #2

Medacta International SA

Press-fit hip femur prosthesis, one-piece
Primary Device ID07630040720014
NIH Device Record Key67a3a674-2f0b-491a-a357-114c9790be8d
Commercial Distribution StatusIn Commercial Distribution
Brand NameAMIStem-P
Version Model Number01.18.402
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
GS107630040720014 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-11-01
Device Publish Date2021-10-22

On-Brand Devices [AMIStem-P]

07630040720175AMIStem-P LAT stem #8
07630040720168AMIStem-P LAT stem #7
07630040720151AMIStem-P LAT stem #6
07630040720144AMIStem-P LAT stem #5
07630040720137AMIStem-P LAT stem #4
07630040720120AMIStem-P LAT stem #3
07630040720113AMIStem-P LAT stem #2
07630040720106AMIStem-P LAT stem #1
07630040720090AMIStem-P LAT stem #0
07630040720083AMIStem-P STD stem #9
07630040720076AMIStem-P STD stem #8
07630040720069AMIStem-P STD stem #7
07630040720052AMIStem-P STD stem #6
07630040720045AMIStem-P STD stem #5
07630040720038AMIStem-P STD stem #4
07630040720021AMIStem-P STD stem #3
07630040720014AMIStem-P STD stem #2
07630040720007AMIStem-P STD stem #1
07630040719995AMIStem-P STD stem #0
07630040719988AMIStem-P STD stem #00

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