FDA.reportPublic FDA data

OrthoMedFlex

Primary DI
M7161111651380
Brand
OrthoMedFlex
Company
ORTHOMEDFLEX LLC
Model
111162138
Catalog number
111-162-138
Device description
Pelion Stem, Standard Cemented - Size 1
Published
2017-10-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MAYProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAYProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic FinishOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M7161111651380PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Uncoated femoral stem prosthesis, one-pieceA sterile implantable device designed to replace the proximal femoral neck as part of a total hip arthroplasty (THA). The device is one-piece, is made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel], and is not coated with materials intended to improve fixation and stability by promoting bone ingrowth. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation is intended to be performed with bone cement.

Regulatory Flags#

DUNS number
034442726
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M7161011020OrthoMedFlex101-1021011022016-08-30
M7161011250OrthoMedFlex101-125101-1252016-08-29
M7161011260OrthoMedFlex101-126101-1262016-08-29
M7161011340OrthoMedFlex101-134101-1342016-08-30
M7161011430OrthoMedFlex, LLC101-143101-1432017-09-19
M716101164280OrthoMedFlex101-164-28101-164-282016-08-29
M716101164360OrthoMedFlex101-164-36101-164-362016-08-29
M7161011710OrthoMedFlex101-171101-1712016-08-29
M7161012260OrthoMedFlex101-226101-2262016-09-01
M7161012290OrthoMedFlex101229101-2292017-03-07
M7161012400OrthoMedFlex101240101-2402017-10-03
M7161012430OrthoMedFlex101-243101-2432021-06-24
M7161013010OrthoMedFlex101-301101-3012016-08-31
M7161013020OrthoMedFlex101-302101-3022016-08-31
M7161013040OrthoMedFlex, LLC101-304101-3042017-04-25
M7161013190OrthoMedFlex101-319101-3192016-08-29
M7161013190210OrthoMedFlex101319021101-319-0212017-02-23
M7161013310OrthoMedFlex, LLC101-331101-3312017-09-19
M7161013510OrthoMedFlex101-351101-3512016-08-31
M7161013520OrthoMedFlex, LLC101-352101-3522017-04-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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07613153071600RestorationHowmedica Osteonics Corp.MAY2015-09-24
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07613153071631RestorationHowmedica Osteonics Corp.MAY2015-09-24
07613153071648RestorationHowmedica Osteonics Corp.MAY2015-09-24
07613153071655RestorationHowmedica Osteonics Corp.MAY2015-09-24
07613153072867TridentHowmedica Osteonics Corp.MAY2015-09-24
07613153072881TridentHowmedica Osteonics Corp.MAY2015-09-24
07613153072898TridentHowmedica Osteonics Corp.MAY2015-09-24
07613153072904TridentHowmedica Osteonics Corp.MAY2015-09-24
07613153072911TridentHowmedica Osteonics Corp.MAY2015-09-24
07613153072928TridentHowmedica Osteonics Corp.MAY2015-09-24