FDA.reportPublic FDA data

Lineage

Primary DI
M684260000141
Brand
Lineage
Company
Microport Orthopedics Inc.
Model
26000014
Catalog number
26000014
Device description
CERAMIC FEMORAL HEAD 36mm SLT TAPER MEDIUM NECK
Published
2016-08-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MRAProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MRAProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or UncementedUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
26000014Direct MarkingHIBCC0
M684260000141PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Ceramic femoral head prosthesisAn implantable artificial substitute for a diseased or injured femoral head that has an outer surface made of ceramic (e.g., alumina, zirconia). It is designed to be attached to the trunnion of a prosthetic femoral stem/shaft or a head/stem adaptor, and to articulate with an acetabulum prosthesis as part of a total hip arthroplasty (THA) or with a bipolar component as part of a partial hip replacement. The device ranges in form from partially to fully spherical (ball-shaped) and is available in various sizes.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter36Millimeter

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
00192629298675ProphecyPNV08001PNV080012020-09-25
00192629298682ProphecyPNV08002PNV080022020-09-25
00192629298699ProphecyPNV08003PNV080032020-09-25
00192629298705ProphecyPNV08004PNV080042020-09-25
00192629298712ProphecyPNV08005PNV080052020-09-25
00192629298729ProphecyPNV08006PNV080062020-09-25
00192629298736ProphecyPNV08007PNV080072020-09-25
00192629298743ProphecyPNV08008PNV080082020-09-25
00192629298750ProphecyPNV08009PNV080092020-09-25
00192629298767ProphecyPNV08010PNV080102020-09-25
00192629298774ProphecyPNV08011PNV080112020-09-25
00192629298781ProphecyPNV08012PNV080122020-09-25
00192629298798ProphecyPNV08013PNV080132020-09-25
00192629298804ProphecyPNV08014PNV080142020-09-25
00192629298811ProphecyPNV08015PNV080152020-09-25
00192629298828ProphecyPNV08016PNV080162020-09-25
00192629298835ProphecyPNV08017PNV080172020-09-25
00192629298842ProphecyPNV08018PNV080182020-09-25
00192629298859ProphecyPNV08019PNV080192020-09-25
00192629298866ProphecyPNV08020PNV080202020-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M684PLS0R4111ProfemurMicroport Orthopedics Inc.MRA2016-09-24
M684PLS0R4121ProfemurMicroport Orthopedics Inc.MRA2016-09-24
M684PLS0R4131ProfemurMicroport Orthopedics Inc.MRA2016-09-24
M684PLS0R4141ProfemurMicroport Orthopedics Inc.MRA2016-09-24
M684PLS0R4161ProfemurMicroport Orthopedics Inc.MRA2016-09-24
M684PLS0S4101ProfemurMicroport Orthopedics Inc.MRA2016-09-24
M684PLS0R4101ProfemurMicroport Orthopedics Inc.MRA2016-09-24
M684PLS0R4151ProfemurMicroport Orthopedics Inc.MRA2016-09-24
M684260000041LineageMicroport Orthopedics Inc.MRA2016-08-31
M684260000051LineageMicroport Orthopedics Inc.MRA2016-08-31
M684260000061LineageMicroport Orthopedics Inc.MRA2016-08-31
M684260000071LineageMicroport Orthopedics Inc.MRA2016-08-31
M684260000081LineageMicroport Orthopedics Inc.MRA2016-08-31
M684260000091LineageMicroport Orthopedics Inc.MRA2016-08-31
M684260000101LineageMicroport Orthopedics Inc.MRA2016-08-31
M684260000111LineageMicroport Orthopedics Inc.MRA2016-08-31
M684260000121LineageMicroport Orthopedics Inc.MRA2016-08-31
M684260000131LineageMicroport Orthopedics Inc.MRA2016-08-31
M684260000151LineageMicroport Orthopedics Inc.MRA2016-08-31
M684365800461LineageMicroport Orthopedics Inc.MRA2016-08-31
M684365800481LineageMicroport Orthopedics Inc.MRA2016-08-31
M684365800501LineageMicroport Orthopedics Inc.MRA2016-08-31
M684365800521LineageMicroport Orthopedics Inc.MRA2016-08-31
M684365800541LineageMicroport Orthopedics Inc.MRA2016-08-31
M684365800561LineageMicroport Orthopedics Inc.MRA2016-08-31
M684365800581LineageMicroport Orthopedics Inc.MRA2016-08-31
M684365800601LineageMicroport Orthopedics Inc.MRA2016-08-31
M684365800621LineageMicroport Orthopedics Inc.MRA2016-08-31
M684365800641LineageMicroport Orthopedics Inc.MRA2016-08-31
M684365800661LineageMicroport Orthopedics Inc.MRA2016-08-31