FDA.reportPublic FDA data

Consensus® Hip System

Primary DI
00844588003387
Brand
Consensus® Hip System
Company
CONSENSUS ORTHOPEDICS, INC.
Model
1410-2-0010
Catalog number
1410-2-0010
Device description
Femoral Stem, Collarless, Cementless, NP, HA Coated
Published
2015-10-24
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
MEHProsthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium PhosphateOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00844588003387PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00844588003387008445880033878445880033870844588003387

GMDN Terms#

Term, Definition table
TermDefinition
Coated femoral stem prosthesis, modularA sterile implantable device designed to replace the proximal femoral neck as part of a total hip arthroplasty (THA). The device is composed of two or more separate segments designed to be joined, typically made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel], and is coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation may be performed with or without 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

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Primary DI, Brand, Company table
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