FDA.reportPublic FDA data

DURAMER®

Primary DI
M68436912852001
Brand
DURAMER®
Company
Microport Orthopedics Inc.
Model
3691285200
Catalog number
3691285200
Device description
DURAMER® ALL POLY CUP 52mm OD 28mm ID
Published
2015-10-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KXAProsthesis, Hip, Femoral, Resurfacing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KXAProsthesis, Hip, Femoral, ResurfacingOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
3691285200Direct MarkingHIBCC0
M68436912852001PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Non-constrained polyethylene acetabular linerA sterile, implantable component of a two-piece acetabulum prosthesis that is inserted into an acetabular shell prosthesis to provide the articulating surface with a femoral head prosthesis as part of a total hip arthroplasty (THA). It is made of polyethylene (includes hylamer, cross-linked polyethylene), and does not include a stabilizing component to limit the range of motion of the hip.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Lumen/Inner Diameter28Millimeter
Outer Diameter52Millimeter

Contacts#

Phone, Email table
PhoneEmail
1-866-872-0211customerservice2@ortho.microport.com

Regulatory Flags#

DUNS number
079118736
Device count
1
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
00192629087255ProfemurPHAC1202PHAC12022026-05-14
00192629087262ProfemurPHAC1204PHAC12042026-05-14
00192629087279ProfemurPHAC1212PHAC12122026-05-14
00192629087286ProfemurPHAC1214PHAC12142026-05-14
00192629087293ProfemurPHAC1222PHAC12222026-05-14
00192629087309ProfemurPHAC1224PHAC12242026-05-14
00192629087316ProfemurPHAC1232PHAC12322026-05-14
00192629087323ProfemurPHAC1234PHAC12342026-05-14
00192629087330ProfemurPHAC1242PHAC12422026-05-14
00192629087347ProfemurPHAC1244PHAC12442026-05-14
00192629087354ProfemurPHAC1252PHAC12522026-05-14
00192629324077ProphecyPNV08601PNV086012021-05-20
00192629324084ProphecyPNV08602PNV086022021-05-20
00192629324091ProphecyPNV08603PNV086032021-05-20
00192629324107ProphecyPNV08604PNV086042021-05-20
00192629324114ProphecyPNV08605PNV086052021-05-20
00192629324121ProphecyPNV08606PNV086062021-05-20
00192629324138ProphecyPNV08607PNV086072021-05-20
00192629324145ProphecyPNV08608PNV086082021-05-20
00192629324152ProphecyPNV08609PNV086092021-05-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09348215185541Signature Resurfacing Femoral HeadSIGNATURE ORTHOPAEDICS PTY LTDKXA2026-07-29
09348215185558Signature Resurfacing Femoral HeadSIGNATURE ORTHOPAEDICS PTY LTDKXA2026-07-29
09348215185565Signature Resurfacing Femoral HeadSIGNATURE ORTHOPAEDICS PTY LTDKXA2026-07-29
09348215185572Signature Resurfacing Femoral HeadSIGNATURE ORTHOPAEDICS PTY LTDKXA2026-07-29
09348215185589Signature Resurfacing Femoral HeadSIGNATURE ORTHOPAEDICS PTY LTDKXA2026-07-29
09348215185596Signature Resurfacing Femoral HeadSIGNATURE ORTHOPAEDICS PTY LTDKXA2026-07-29
09348215185602Signature Resurfacing Femoral HeadSIGNATURE ORTHOPAEDICS PTY LTDKXA2026-07-29
09348215185619Signature Resurfacing Femoral HeadSIGNATURE ORTHOPAEDICS PTY LTDKXA2026-07-29
09348215185626Signature Resurfacing Femoral HeadSIGNATURE ORTHOPAEDICS PTY LTDKXA2026-07-29
09348215185633Signature Resurfacing Femoral HeadSIGNATURE ORTHOPAEDICS PTY LTDKXA2026-07-29
09348215185640Signature Resurfacing Femoral HeadSIGNATURE ORTHOPAEDICS PTY LTDKXA2026-07-29
09348215185657Signature Resurfacing Femoral HeadSIGNATURE ORTHOPAEDICS PTY LTDKXA2026-07-29
00814193025654SYNOVO HIP COMPONENTSSynovo ProductionKXA2024-03-02
00814193025661SYNOVO HIP COMPONENTSSynovo ProductionKXA2024-03-02
00814193025678SYNOVO HIP COMPONENTSSynovo ProductionKXA2024-03-02
00814193025685SYNOVO HIP COMPONENTSSynovo ProductionKXA2024-03-02
00814193025692SYNOVO HIP COMPONENTSSynovo ProductionKXA2024-03-02
00814193025708SYNOVO HIP COMPONENTSSynovo ProductionKXA2024-03-02
00814193025715SYNOVO HIP COMPONENTSSynovo ProductionKXA2024-03-02
00814193025722SYNOVO HIP COMPONENTSSynovo ProductionKXA2024-03-02
00814193025753SYNOVO HIP COMPONENTSSynovo ProductionKXA2024-03-02
00814193025739SYNOVO HIP COMPONENTSSynovo ProductionKXA2024-03-01
00814193025746SYNOVO HIP COMPONENTSSynovo ProductionKXA2024-03-01
00810068850383Biocore9 Femoral Resurfacing ComponentBiocore9, LLCKXA2021-09-27
00810068850390Biocore9 Femoral Resurfacing ComponentBiocore9, LLCKXA2021-09-27
00810068850406Biocore9 Femoral Resurfacing ComponentBiocore9, LLCKXA2021-09-27
00810068850413Biocore9 Femoral Resurfacing ComponentBiocore9, LLCKXA2021-09-27
00810068850420Biocore9 Femoral Resurfacing ComponentBiocore9, LLCKXA2021-09-27
00810068850437Biocore9 Femoral Resurfacing ComponentBiocore9, LLCKXA2021-09-27
00810068850444Biocore9 Femoral Resurfacing ComponentBiocore9, LLCKXA2021-09-27