FDA.reportPublic FDA data

Profemur

Primary DI
M684PHA029251
Brand
Profemur
Company
Microport Orthopedics Inc.
Model
PHA02925
Catalog number
PHA02925
Device description
SHELL SCREW D=5.5 L=25
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
PHA02925Direct MarkingHIBCC0
M684PHA029251PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw, non-bioabsorbable, sterile"A small, sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). There are a number of kinds available: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A ""lag screw"" can be any of these used to obtain compression across bone fragments."

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length25Millimeter
Outer Diameter5.5Millimeter

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
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
M684260000141LineageMicroport 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