FDA.reportPublic FDA data

Consensus® Hip System

Primary DI
00844588001871
Brand
Consensus® Hip System
Company
CONSENSUS ORTHOPEDICS, INC.
Model
1012-0-0010
Catalog number
1012-0-0010
Device description
Femoral Stem, Collared, Tapered, Cemented
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
JDLProsthesis, hip, semi-constrained (metal cemented acetabular component)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDLProsthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)Orthopedic3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00844588001871PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00844588001871008445880018718445880018710844588001871

GMDN Terms#

Term, Definition table
TermDefinition
Uncoated femoral stem prosthesis, one-pieceA sterile implantable device designed to replace the proximal femoral neck as part of a total hip arthroplasty (THA). The device is one-piece, is made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel], and is not coated with materials intended to improve fixation and stability by promoting bone ingrowth. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation is intended to be performed with bone cement.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter10Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
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 DI, Brand, Model table
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 DI, Brand, Company table
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