FDA.report

Implant Partners

Primary DI
26000028WD
Brand
Implant Partners
Company
Microport Orthopedics Inc.
Model
26000028WD
Catalog number
26000028WD
Device description
COCR SF FEM HEAD 36MM SLT TPR XLNG NK IMPLANT PARTNERS™
Published
2015-10-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
JDLProsthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)

Product Code Classifications

CodeDeviceSpecialtyClass
JDLProsthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)Orthopedic3

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
26000028WDDirect MarkingHIBCC0
M68426000028WD1PrimaryHIBCC0

GMDN Terms

TermDefinition
Metallic femoral head prosthesisAn implantable artificial substitute for a diseased or injured femoral head that has an outer surface made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel]. 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 articulate with the natural acetabulum directly or via a bipolar component as part of a partial hip arthroplasty (hemiarthroplasty). The device ranges in form from partially to fully spherical (ball-shaped) and is available in various sizes.

Device Sizes

TypeValueUnit
Lumen/Inner Diameter36Millimeter

Sterilization Methods

Method

Contacts

PhoneEmail
1-866-872-0211customerservice2@ortho.microport.com

Regulatory Flags

DUNS number
079118736
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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M684PNV123761ProphecyPNV12376PNV123762026-02-03
M684PNV123771ProphecyPNV12377PNV123772026-02-03
M684PNV123781ProphecyPNV12378PNV123782026-02-03
M684PNV123791ProphecyPNV12379PNV123792026-02-03
M684PNV123801ProphecyPNV12380PNV123802026-02-03
M684PNV123811ProphecyPNV12381PNV123812026-02-03
M684PNV123821ProphecyPNV12382PNV123822026-02-03
M684PNV123831ProphecyPNV12383PNV123832026-02-03
M684PNV123841ProphecyPNV12384PNV123842026-02-03
M684PNV123851ProphecyPNV12385PNV123852026-02-03
M684PNV123861ProphecyPNV12386PNV123862026-02-03
M684PNV123871ProphecyPNV12387PNV123872026-02-03
M684PNV123881ProphecyPNV12388PNV123882026-02-03
M684PNV123891ProphecyPNV12389PNV123892026-02-03
M684PNV123901ProphecyPNV12390PNV123902026-02-03
M684PNV123911ProphecyPNV12391PNV123912026-02-03
M684PNV123921ProphecyPNV12392PNV123922026-02-03
M684PNV123931ProphecyPNV12393PNV123932026-02-03

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