Quadra P femoral stems

GUDID 07630040720571

Quadra-P LAT stem #5

Medacta International SA

Press-fit hip femur prosthesis, one-piece Press-fit hip femur prosthesis, one-piece Press-fit hip femur prosthesis, one-piece Press-fit hip femur prosthesis, one-piece Press-fit hip femur prosthesis, one-piece Press-fit hip femur prosthesis, one-piece Press-fit hip femur prosthesis, one-piece Press-fit hip femur prosthesis, one-piece Press-fit hip femur prosthesis, one-piece Press-fit hip femur prosthesis, one-piece
Primary Device ID07630040720571
NIH Device Record Keyed0f164c-7c1d-4c0c-a8e9-c53ec35d90a3
Commercial Distribution StatusIn Commercial Distribution
Brand NameQuadra P femoral stems
Version Model Number01.12.145
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
GS107630040720571 [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 Date2021-11-02
Device Publish Date2021-10-25

On-Brand Devices [Quadra P femoral stems]

07630971243620Quadra-P Short Neck LAT stem #10
07630971243613Quadra-P Short Neck LAT stem #9
07630971243606Quadra-P Short Neck LAT stem #8
07630971243590Quadra-P Short Neck LAT stem #7
07630971243583Quadra-P Short Neck LAT stem #6
07630971243576Quadra-P Short Neck LAT stem #5
07630971243569Quadra-P Short Neck LAT stem #4
07630971243552Quadra-P Short Neck LAT stem #3
07630971243545Quadra-P Short Neck LAT stem #2
07630971243538Quadra-P Short Neck LAT stem #1
07630971243521Quadra-P Short Neck LAT stem #0
07630971243514Quadra-P Short Neck STD stem #10
07630971243507Quadra-P Short Neck STD stem #9
07630971243491Quadra-P Short Neck STD stem #8
07630971243484Quadra-P Short Neck STD stem #7
07630971243477Quadra-P Short Neck STD stem #6
07630971243460Quadra-P Short Neck STD stem #5
07630971243453Quadra-P Short Neck STD stem #4
07630971243446Quadra-P Short Neck STD stem #3
07630971243439Quadra-P Short Neck STD stem #2
07630971243422Quadra-P Short Neck STD stem #1
07630971243415Quadra-P Short Neck STD stem #0
07630040732246Quadra-P Cemented LAT stem #8
07630040732239Quadra-P Cemented LAT stem #7
07630040732222Quadra-P Cemented LAT stem #6
07630040732215Quadra-P Cemented LAT stem #5
07630040732208Quadra-P Cemented LAT stem #4
07630040732192Quadra-P Cemented LAT stem #3
07630040732185Quadra-P Cemented LAT stem #2
07630040732178Quadra-P Cemented LAT stem #1
07630040732161Quadra-P Cemented LAT stem #0
07630040732154Quadra-P Cemented STD stem #8
07630040732147Quadra-P Cemented STD stem #7
07630040732130Quadra-P Cemented STD stem #6
07630040732123Quadra-P Cemented STD stem #5
07630040732116Quadra-P Cemented STD stem #4
07630040732109Quadra-P Cemented STD stem #3
07630040732093Quadra-P Cemented STD stem #2
07630040732086Quadra-P Cemented STD stem #1
07630040732079Quadra-P Cemented STD stem #0
07630040732055Quadra-P Collared LAT stem #10
07630040732048Quadra-P Collared LAT stem #9
07630040732031Quadra-P Collared LAT stem #8
07630040732024Quadra-P Collared LAT stem #7
07630040732017Quadra-P Collared LAT stem #6
07630040732000Quadra-P Collared LAT stem #5
07630040731997Quadra-P Collared LAT stem #4
07630040731980Quadra-P Collared LAT stem #3
07630040731973Quadra-P Collared LAT stem #2
07630040731966Quadra-P Collared LAT stem #1

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