FDA.reportPublic FDA data

OrthoMedFlex

Primary DI
M716AS725P0
Brand
OrthoMedFlex
Company
ORTHOMEDFLEX LLC
Model
AS-725P
Catalog number
AS-725P
Device description
Cement Plug, Size 25mm, LLDPE
Published
2015-11-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium PhosphateOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M716AS725P0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Polymer orthopaedic cement restrictor, non-bioabsorbableA non-bioabsorbable, implantable device designed to be inserted into the medullary canal of a bone (e.g., femur, tibia, or humerus) during orthopaedic surgery to prevent cement progression in the diaphysis and therefore facilitate cement pressurization during the introduction of an implant. It is typically made of polyetheretherketone (PEEK) or ultrahigh molecular weight polyethylene (UHMWPE) and is available in a variety of designs (e.g., straight or tapered, hollow with a fenestrated surface), and it may have a toothed surface to prevent its migration from the desired location. It may incorporate a metal orientation marker for radiographs and it is not intended for spinal application.

Contacts#

Phone, Email table
PhoneEmail
1-844-663-3539info@orthomedflex.com

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
Primary DIBrandCompanyProduct codePublished
04719886896602United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899030United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899047United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899054United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899061United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899078United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899085United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899092United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899108United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899115United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899122United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899139United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899146United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899153United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899160United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899177United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899184United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899191United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899207United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899214United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899221United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899238United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899245United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899252United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886910896United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886913361Momentum Acetabular Cup SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886913378Momentum Acetabular Cup SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886913385Momentum Acetabular Cup SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886913392Momentum Acetabular Cup SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886913408Momentum Acetabular Cup SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15