FDA.report

Consensus® Hip System

Primary DI
00844588004124
Brand
Consensus® Hip System
Company
CONSENSUS ORTHOPEDICS, INC.
Model
1704-0-0048
Catalog number
1704-0-0048
Device description
Acetabular Shell, No Hole, Cementless, PC
Published
2015-09-24
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
00844588004124PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00844588004124008445880041248445880041240844588004124

GMDN Terms

TermDefinition
Acetabular shellA sterile, implantable component of a two-piece acetabulum prosthesis that forms the outer portion of the prosthesis, fixed to the pelvis to provide a base for the inner portion (acetabular liner). It is made of metal, and is fixed with bone cement and/or fixation devices.

Device Sizes

TypeValueUnit
Outer Diameter48Millimeter

Sterilization Methods

Method

Contacts

PhoneEmail
+1(916)355-7100zjohnson@consensusortho.com

Regulatory Flags

DUNS number
824905723
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
true
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00844588044311TracPatch4000-0-10004000-0-10002020-03-26
00844588006111Consensus® Knee System2151-0-00012151-0-00012015-10-05
00844588006128Consensus® Knee System2151-0-00022151-0-00022015-10-05
00844588006135Consensus® Knee System2151-0-00032151-0-00032015-10-05
00844588006142Consensus® Knee System2151-0-00042151-0-00042015-10-05
00844588006159Consensus® Knee System2151-0-00052151-0-00052015-10-05
00844588006166Consensus® Knee System2151-0-00062151-0-00062015-10-05
00844588006173Consensus® Knee System2152-0-00012152-0-00012015-10-05
00844588006180Consensus® Knee System2152-0-00022152-0-00022015-10-05
00844588006197Consensus® Knee System2152-0-00032152-0-00032015-10-05
00844588006203Consensus® Knee System2152-0-00042152-0-00042015-10-05
00844588006210Consensus® Knee System2152-0-00052152-0-00052015-10-05
00844588006227Consensus® Knee System2152-0-00062152-0-00062015-10-05
00844588006234Consensus® Knee System2153-0-00012153-0-00012015-10-05
00844588006241Consensus® Knee System2153-0-00022153-0-00022015-10-05
00844588006258Consensus® Knee System2153-0-00032153-0-00032015-10-05
00844588006265Consensus® Knee System2153-0-00042153-0-00042015-10-05
00844588006272Consensus® Knee System2153-0-00052153-0-00052015-10-05
00844588006289Consensus® Knee System2153-0-00062153-0-00062015-10-05
00844588006296Consensus® Knee System2154-0-00012154-0-00012015-10-05

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