AMIStem H Femoral Stems

GUDID 07630030803765

AMIStem H Cementless Stem Standard size 00

Medacta International SA

Press-fit hip femur prosthesis, one-piece
Primary Device ID07630030803765
NIH Device Record Keye0090fd2-87f3-4034-a15a-413c6783579b
Commercial Distribution StatusIn Commercial Distribution
Brand NameAMIStem H Femoral Stems
Version Model Number01.18.098
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
GS107630030803765 [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 H Femoral Stems]

07630030804243AMIStem H Cementless Stem Lateralized size 8
07630030804236AMIStem H Cementless Stem Lateralized size 7
07630030804229AMIStem H Cementless Stem Lateralized size 6
07630030804212AMIStem H Cementless Stem Lateralized size 5
07630030804205AMIStem H Cementless Stem Lateralized size 4
07630030804199AMIStem H Cementless Stem Lateralized size 3
07630030804182AMIStem H Cementless Stem Lateralized size 2
07630030804175AMIStem H Cementless Stem Lateralized size 1
07630030804168AMIStem H Cementless Stem Lateralized size 0
07630030804151AMIStem H Cementless Stem Standard size 9
07630030804144AMIStem H Cementless Stem Standard size 8
07630030804137AMIStem H Cementless Stem Standard size 7
07630030804120AMIStem H Cementless Stem Standard size 6
07630030804113AMIStem H Cementless Stem Standard size 5
07630030804106AMIStem H Cementless Stem Standard size 4
07630030804090AMIStem H Cementless Stem Standard size 3
07630030804083AMIStem H Cementless Stem Standard size 2
07630030804076AMIStem H Cementless Stem Standard size 1
07630030804069AMIStem H Cementless Stem Standard size 0
07630030803765AMIStem H Cementless Stem Standard size 00

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.