Amis K Long femoral stems

GUDID 07630971265646

AMIS-K LONG Size 5R1 Length 200mm

Medacta International SA

Press-fit hip femur prosthesis, one-piece
Primary Device ID07630971265646
NIH Device Record Keyec56ccfe-1f44-4ede-b5de-bdfcebc42711
Commercial Distribution StatusIn Commercial Distribution
Brand NameAmis K Long femoral stems
Version Model Number01.20.218
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
GS107630971265646 [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 Date2022-04-29
Device Publish Date2022-04-21

On-Brand Devices [Amis K Long femoral stems]

07630971265660AMIS-K LONG Size 5R1 Length 300mm
07630971265653AMIS-K LONG Size 5R1 Length 250mm
07630971265646AMIS-K LONG Size 5R1 Length 200mm
07630971265639AMIS-K LONG Size 4S2 Length 300mm
07630971265622AMIS-K LONG Size 4S2 Length 250mm
07630971265615AMIS-K LONG Size 4S2 Length 200mm
07630971265608AMIS-K LONG Size 4S1 Length 300mm
07630971265592AMIS-K LONG Size 4S1 Length 250mm
07630971265585AMIS-K LONG Size 4S1 Length 200mm
07630971265578AMIS-K LONG Size 3S2 Length 300mm
07630971265561AMIS-K LONG Size 3S2 Length 250mm
07630971265554AMIS-K LONG Size 3S2 Length 200mm
07630971265547AMIS-K LONG Size 3S1 Length 300mm
07630971265530AMIS-K LONG Size 3S1 Length 250mm
07630971265523AMIS-K LONG Size 3S1 Length 200mm
07630971265516AMIS-K LONG Size 2S2 Length 300mm
07630971265509AMIS-K LONG Size 2S2 Length 250mm
07630971265493AMIS-K LONG Size 2S2 Length 200mm
07630971265486AMIS-K LONG Size 2S1 Length 300mm
07630971265479AMIS-K LONG Size 2S1 Length 250mm
07630971265462AMIS-K LONG Size 2S1 Length 200mm

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