AMIStem-P Short Neck

GUDID 07630971243675

AMIStem-P Short Neck STD stem #3

Medacta International SA

Press-fit hip femur prosthesis, one-piece
Primary Device ID07630971243675
NIH Device Record Key329c7d3f-00a7-4191-a3b0-b9f89ed30bab
Commercial Distribution StatusIn Commercial Distribution
Brand NameAMIStem-P Short Neck
Version Model Number01.18.463
Company DUNS488227125
Company NameMedacta International SA
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
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
GS107630971243675 [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 Date2020-02-06
Device Publish Date2020-01-29

On-Brand Devices [AMIStem-P Short Neck ]

07630971243828AMIStem- P Short Neck LAT stem #8
07630971243811AMIStem- P Short Neck LAT stem #7
07630971243804AMIStem- P Short Neck LAT stem #6
07630971243798AMIStem- P Short Neck LAT stem #5
07630971243781AMIStem- P Short Neck LAT stem #4
07630971243774AMIStem- P Short Neck LAT stem #3
07630971243767AMIStem- P Short Neck LAT stem #2
07630971243750AMIStem- P Short Neck LAT stem #1
07630971243743AMIStem- P Short Neck LAT stem #0
07630971243736AMIStem-P Short Neck STD stem #9
07630971243729AMIStem-P Short Neck STD stem #8
07630971243712AMIStem-P Short Neck STD stem #7
07630971243705AMIStem-P Short Neck STD stem #6
07630971243699AMIStem-P Short Neck STD stem #5
07630971243682AMIStem-P Short Neck STD stem #4
07630971243675AMIStem-P Short Neck STD stem #3
07630971243668AMIStem-P Short Neck STD stem #2
07630971243651AMIStem-P Short Neck STD stem #1
07630971243644AMIStem-P Short Neck STD stem #0
07630971243637AMIStem-P Short Neck STD stem #00

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