Mpact Acetabular System

GUDID 07630030810220

Acetabular Shell Two Holes Ø50

Medacta International SA

Acetabular shell
Primary Device ID07630030810220
NIH Device Record Keyc96f3592-0530-4080-ac8b-0c87a36c00c3
Commercial Distribution StatusIn Commercial Distribution
Brand NameMpact Acetabular System
Version Model Number01.32.050DH
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
GS107630030810220 [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 [Mpact Acetabular System]

07630030860911Mpact Shell screw plug
07630030812477Cancellous bone screw, flat head Ø 6,5 L 70
07630030812460Cancellous bone screw, flat head Ø 6,5 L 65
07630030812453Cancellous bone screw, flat head Ø 6,5 L 60
07630030812446Cancellous bone screw, flat head Ø 6,5 L 55
07630030812439Cancellous bone screw, flat head Ø 6,5 L 50
07630030812422Cancellous bone screw flat head Ø 6,5 L45
07630030812415Cancellous bone screw flat head Ø 6,5 L40
07630030812408Cancellous bone screw flat head Ø 6,5 L35
07630030812392Cancellous bone screw flat head Ø 6,5 L30
07630030812385Cancellous bone screw flat head Ø 6,5 L25
07630030812378Cancellous bone screw flat head Ø 6,5 L20
07630030812361Cancellous bone screw flat head Ø 6,5 L15
07630030812316Flat PE HC liner Ø 40 / K
07630030812309Flat PE HC liner Ø 40 / J
07630030812293Cortical bone screw flat head Ø 4 L55
07630030812286Flat PE HC liner Ø 40 / G
07630030812279Cortical bone screw flat head Ø 4 L50
07630030812262Flat PE HC liner Ø 40 / F
07630030812255Cortical bone screw flat head Ø 4 L45
07630030812248Cortical bone screw flat head Ø 4 L40
07630030812231Cortical bone screw flat head Ø 4 L35
07630030812224Cortical bone screw flat head Ø 4 L30
07630030812217Cortical bone screw flat head Ø 4 L25
07630030812194Flat PE HC liner Ø 36 / K
07630030812187Hooded PE HC liner Ø 36 / K
07630030812170Flat PE HC liner Ø 36 / J
07630030812163Hooded PE HC liner Ø 36 / J
07630030812156Flat PE HC liner Ø 36 / G
07630030812149Hooded PE HC Liner Ø 36 / G
07630030812132Flat PE HC liner Ø 36 / F
07630030812125Hooded PE HC Liner Ø 36 / F
07630030812118Flat PE HC liner Ø 36 / E
07630030812101Hooded PE HC Liner Ø 36 / E
07630030812088Flat PE liner Ø 32 / K
07630030812071Flat PE HC liner Ø 32 / K
07630030812064Hooded PE HC liner Ø 32 / K
07630030812057Hooded PE liner Ø 32 / K
07630030812040Flat PE liner Ø 32 / J
07630030812033Flat PE HC liner Ø 32 / J
07630030812026Hooded PE HC liner Ø 32 / J
07630030812019Hooded PE liner Ø 32 / J
07630030812002Flat PE liner Ø 32 / G
07630030811999Flat PE HC liner Ø 32 /G
07630030811982Hooded PE HC Liner Ø 32 / G
07630030811975Hooded PE Liner Ø 32 / G
07630030811968Flat PE liner Ø 32 / F
07630030811951Flat PE HC liner Ø 32 / F
07630030811944Hooded PE HC Liner Ø 32 / F
07630030811937Hooded PE Liner Ø 32 / F

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