OrthoMedFlex, LLC 112-152-527

GUDID M7161121525270

Trial Liner, 40/56-58D (20 degree Hooded)

ORTHOMEDFLEX LLC

Acetabulum prosthesis trial, prefabricated, reusable
Primary Device IDM7161121525270
NIH Device Record Key82d17dc2-2f99-4a4b-a995-fef559b80943
Commercial Distribution StatusIn Commercial Distribution
Brand NameOrthoMedFlex, LLC
Version Model Number112-152-527
Catalog Number112-152-527
Company DUNS034442726
Company NameORTHOMEDFLEX LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone844-663-3539
Emailinfo@orthomedflex.com
Phone844-663-3539
Emailinfo@orthomedflex.com
Phone844-663-3539
Emailinfo@orthomedflex.com
Phone844-663-3539
Emailinfo@orthomedflex.com
Phone844-663-3539
Emailinfo@orthomedflex.com
Phone844-663-3539
Emailinfo@orthomedflex.com
Phone844-663-3539
Emailinfo@orthomedflex.com
Phone844-663-3539
Emailinfo@orthomedflex.com
Phone844-663-3539
Emailinfo@orthomedflex.com
Phone844-663-3539
Emailinfo@orthomedflex.com
Phone844-663-3539
Emailinfo@orthomedflex.com
Phone844-663-3539
Emailinfo@orthomedflex.com
Phone844-663-3539
Emailinfo@orthomedflex.com
Phone844-663-3539
Emailinfo@orthomedflex.com
Phone844-663-3539
Emailinfo@orthomedflex.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM7161121525270 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M7161121525270]

Moist Heat or Steam Sterilization

[M7161121525270]

Moist Heat or Steam Sterilization

[M7161121525270]

Moist Heat or Steam Sterilization

[M7161121525270]

Moist Heat or Steam Sterilization

[M7161121525270]

Moist Heat or Steam Sterilization

[M7161121525270]

Moist Heat or Steam Sterilization

[M7161121525270]

Moist Heat or Steam Sterilization

[M7161121525270]

Moist Heat or Steam Sterilization

[M7161121525270]

Moist Heat or Steam Sterilization

[M7161121525270]

Moist Heat or Steam Sterilization

[M7161121525270]

Moist Heat or Steam Sterilization

[M7161121525270]

Moist Heat or Steam Sterilization

[M7161121525270]

Moist Heat or Steam Sterilization

[M7161121525270]

Moist Heat or Steam Sterilization

[M7161121525270]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-12-21
Device Publish Date2018-06-25

On-Brand Devices [OrthoMedFlex, LLC]

M7161121584600Trial Liner, 40/60-68E (+4 10° Hooded Lateralised)
M7161121584560Trial Liner, 40/56-58D (+4 10° Hooded Lateralised)
M7161121574600Trial Liner, 40/60-68E (+4 Neutral Lateralised)
M7161121574560Trial Liner, 40/56-58D (+4 Neutral Lateralised)
M7161111526440Ceramic Femoral Head, 40mm +8mm (XL)
M716AH15400Femoral Head, SIZE 40mm (XL) CoCr Alloy (+10mm)
M716AH14400Femoral Head, SIZE 40mm (XL) CoCr Alloy
M716AH13400Femoral Head SIZE 40mm, (L) CoCr Alloy
M716AH12400Femoral Head, SIZE 40mm (M) CoCr Alloy
M716AH11400Femoral Head, SIZE 40mm, (S) CoCr Alloy
M7161111912010Orion Stem, H/O (Lateralized), - Size 12
M7161111912000Orion Stem, Standard Offset, Size 12
M7161122800370Stepped Reamer
M7161013140Curved Reamer Assembly
M716101199S0Quick Connect Drill Bit, 35mm (Sterile)
M716101198S0Quick Connect Drill Bit (sterile)
M7161011350IM Drill Reamer
M7161011220Tapered Pin Reamer
M7161011200Stepped Entry Reamer
M716AH34400Ceramic Femoral Head, 40mm +8.0mm (XL)
M716AH33400Cermaic Femoral Head, 40mm +4.0mm (L)
M716AH32400Ceramic Femoral Head, 40mm +0.0mm (M)
M716AH31400Ceramic Femoral Head, 40mm -4.0mm (S)
M716101661020Non-Cemented Stem Magazine Insert - Orion
M716101661010Non-Cemented Stem Magazine Insert - Kratos
M7161016610Super Tray with Kratos & Orion Inserts
M7161016600Mudbox Tray used for transporting miscellaneous instruments.
M7161121525280Trial Liner, 40/60-68E (20 degree Hooded)
M7161121525270Trial Liner, 40/56-58D (20 degree Hooded)
M7161121521670Trial Liner, 40/60-68E (Neutral)
M7161121521660Trial Liner, 40/56-58D (Neutral)
M7161121521430Trial Liner, 40/60-68E (10 degree Hooded)
M7161121521420Trial Liner, 40/56-58D (10 degree Hooded)
M7161013450Femoral Rasp
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