PROFEMUR TL2 PRTL2SP9

GUDID M684PRTL2SP91

PROFEMUR TL2 STEM SZ 9+ STANDARD NECK

Microport Orthopedics Inc.

Press-fit femoral stem prosthesis
Primary Device IDM684PRTL2SP91
NIH Device Record Key559536b9-7140-4711-ba13-c26d5c0062d1
Commercial Distribution StatusIn Commercial Distribution
Brand NamePROFEMUR TL2
Version Model NumberPRTL2SP9
Catalog NumberPRTL2SP9
Company DUNS079118736
Company NameMicroport Orthopedics Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(866)872-0211
EmailStephen.Weaver@ortho.microport.com
Phone+1(866)872-0211
EmailStephen.Weaver@ortho.microport.com
Phone+1(866)872-0211
EmailStephen.Weaver@ortho.microport.com
Phone+1(866)872-0211
EmailStephen.Weaver@ortho.microport.com
Phone+1(866)872-0211
EmailStephen.Weaver@ortho.microport.com
Phone+1(866)872-0211
EmailStephen.Weaver@ortho.microport.com
Phone+1(866)872-0211
EmailStephen.Weaver@ortho.microport.com
Phone+1(866)872-0211
EmailStephen.Weaver@ortho.microport.com
Phone+1(866)872-0211
EmailStephen.Weaver@ortho.microport.com
Phone+1(866)872-0211
EmailStephen.Weaver@ortho.microport.com
Phone+1(866)872-0211
EmailStephen.Weaver@ortho.microport.com
Phone+1(866)872-0211
EmailStephen.Weaver@ortho.microport.com
Phone+1(866)872-0211
EmailStephen.Weaver@ortho.microport.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100192629396135 [Primary]
HIBCCM684PRTL2SP91 [Secondary]

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 Date2024-03-21
Device Publish Date2024-03-13

On-Brand Devices [PROFEMUR TL2]

M684PRTL2BP91PROFEMUR TL2 BROACH SZ 9+
M684PRTL2BP81PROFEMUR TL2 BROACH SZ 8+
M684PRTL2BP51PROFEMUR TL2 BROACH SZ 5+
M684PRTL2EP91PROFEMUR® TL2 STEM SZ 9+ HIGH OFFSET NECK
M684PRTL2EP81PROFEMUR® TL2 STEM SZ 8+ HIGH OFFSET NECK
M684PRTL2EP51PROFEMUR TL2 STEM SZ 5+ HIGH OFFSET NECK
M684PRTL2SP91PROFEMUR TL2 STEM SZ 9+ STANDARD NECK
M684PRTL2SP81PROFEMUR TL2 STEM SZ 8+ STANDARD NECK
M684PRTL2SP51PROFEMUR TL2 STEM SZ 5+ STANDARD NECK

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