FDA.report

TRANSCEND®

Primary DI
26000022
Brand
TRANSCEND®
Company
Microport Orthopedics Inc.
Model
26000022
Catalog number
26000022
Device description
COCR TRANSCEND® FEMORAL HEAD 32MM SLT TAPER MEDIUM NECK
Published
2015-10-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
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
26000022Direct MarkingHIBCC0
M684260000221PrimaryHIBCC0

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
Outer Diameter32Millimeter

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

Other Devices From This Company

Primary DIBrandModelCatalogPublished
M684PNV123741ProphecyPNV12374PNV123742026-02-03
M684PNV123751ProphecyPNV12375PNV123752026-02-03
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

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00840286808439Consensus Hip SystemShalby Advanced Technologies, Inc.JDL2022-01-17
00840286808446Consensus Hip SystemShalby Advanced Technologies, Inc.JDL2022-01-17
00840286808453Consensus Hip SystemShalby Advanced Technologies, Inc.JDL2022-01-17
00840286808460Consensus Hip SystemShalby Advanced Technologies, Inc.JDL2022-01-17
00840286808477Consensus Hip SystemShalby Advanced Technologies, Inc.JDL2022-01-17
00840286808484Consensus Hip SystemShalby Advanced Technologies, Inc.JDL2022-01-17
00840286808491Consensus Hip SystemShalby Advanced Technologies, Inc.JDL2022-01-17
00840286808507Consensus Hip SystemShalby Advanced Technologies, Inc.JDL2022-01-17
00840286808514Consensus Hip SystemShalby Advanced Technologies, Inc.JDL2022-01-17
00840286808521Consensus Hip SystemShalby Advanced Technologies, Inc.JDL2022-01-17
00840286808538Consensus Hip SystemShalby Advanced Technologies, Inc.JDL2022-01-17
00840286808545Consensus Hip SystemShalby Advanced Technologies, Inc.JDL2022-01-17
00840286808552Consensus Hip SystemShalby Advanced Technologies, Inc.JDL2022-01-17
00840286808569Consensus Hip SystemShalby Advanced Technologies, Inc.JDL2022-01-17
00840286808576Consensus Hip SystemShalby Advanced Technologies, Inc.JDL2022-01-17
00840286808583Consensus Hip SystemShalby Advanced Technologies, Inc.JDL2022-01-17
00840286808590Consensus Hip SystemShalby Advanced Technologies, Inc.JDL2022-01-17
00840286808606Consensus Hip SystemShalby Advanced Technologies, Inc.JDL2022-01-17
00840286808613Consensus Hip SystemShalby Advanced Technologies, Inc.JDL2022-01-17
00840286808620Consensus Hip SystemShalby Advanced Technologies, Inc.JDL2022-01-17
00840286808637Consensus Hip SystemShalby Advanced Technologies, Inc.JDL2022-01-17
00840286808644Consensus Hip SystemShalby Advanced Technologies, Inc.JDL2022-01-17
00840286808651Consensus Hip SystemShalby Advanced Technologies, Inc.JDL2022-01-17
00840286808668Consensus Hip SystemShalby Advanced Technologies, Inc.JDL2022-01-17
00840286808675Consensus Hip SystemShalby Advanced Technologies, Inc.JDL2022-01-17
00840286808682Consensus Hip SystemShalby Advanced Technologies, Inc.JDL2022-01-17
00840286808699Consensus Hip SystemShalby Advanced Technologies, Inc.JDL2022-01-17
00840286808705Consensus Hip SystemShalby Advanced Technologies, Inc.JDL2022-01-17
00840286802000Consensus Hip SystemShalby Advanced Technologies, Inc.JDL2022-01-15
00840286802017Consensus Hip SystemShalby Advanced Technologies, Inc.JDL2022-01-15