SMS Stem

GUDID 07630345701695

SMS Collared Solid Stem STD #2

Medacta International SA

Press-fit hip femur prosthesis, one-piece
Primary Device ID07630345701695
NIH Device Record Keyd10b48f8-7588-4213-945a-866b52368a9a
Commercial Distribution StatusIn Commercial Distribution
Brand NameSMS Stem
Version Model Number01.36.142
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
GS107630345701695 [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 Date2021-01-29
Device Publish Date2021-01-21

On-Brand Devices [SMS Stem]

07630030888854SMS Solid Stem LAT #13
07630030888847SMS Solid Stem LAT #12
07630030888830SMS Solid Stem LAT #11
07630030888823SMS Solid Stem LAT #10
07630030888816SMS Solid Stem LAT #9
07630030888809SMS Solid Stem LAT #8
07630030888793SMS Solid Stem LAT #7
07630030888786SMS Solid Stem LAT #6
07630030888779SMS Solid Stem LAT #5
07630030888762SMS Solid Stem LAT #4
07630030888755SMS Solid Stem LAT #3
07630030888724SMS Solid Stem STD #13
07630030888717SMS Solid Stem STD #12
07630030888700SMS Solid Stem STD #11
07630030888694SMS Solid Stem STD #10
07630030888687SMS Solid Stem STD #9
07630030888670SMS Solid Stem STD #8
07630030888663SMS Solid Stem STD #7
07630030888656SMS Solid Stem STD #6
07630030888649SMS Solid Stem STD #5
07630030888632SMS Solid Stem STD #4
07630030888625SMS Solid Stem STD #3
07630971292062SMS Solid Stem V2 LAT #2
07630971292055SMS Solid Stem V2 LAT #1
07630971292048SMS Solid Stem LAT #15
07630971292031SMS Solid Stem LAT #14
07630971292024SMS Solid Stem V2 STD #2
07630971292017SMS Solid Stem V2 STD #1
07630971292000SMS Solid Stem STD #15
07630971291997SMS Solid Stem STD #14
07630345701978SMS Collared Solid Stem LAT #15
07630345701961SMS Collared Solid Stem LAT #14
07630345701954SMS Collared Solid Stem LAT #13
07630345701947SMS Collared Solid Stem LAT #12
07630345701930SMS Collared Solid Stem LAT #11
07630345701923SMS Collared Solid Stem LAT #10
07630345701916SMS Collared Solid Stem LAT #9
07630345701909SMS Collared Solid Stem LAT #8
07630345701893SMS Collared Solid Stem LAT #7
07630345701886SMS Collared Solid Stem LAT #6
07630345701879SMS Collared Solid Stem LAT #5
07630345701862SMS Collared Solid Stem LAT #4
07630345701855SMS Collared Solid Stem LAT #3
07630345701848SMS Collared Solid Stem LAT #2
07630345701831SMS Collared Solid Stem LAT #1
07630345701824SMS Collared Solid Stem STD #15
07630345701817SMS Collared Solid Stem STD #14
07630345701800SMS Collared Solid Stem STD #13
07630345701794SMS Collared Solid Stem STD #12
07630345701787SMS Collared Solid Stem STD #11
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