FDA.reportPublic FDA data

CS2 Acetabular Cup System

Primary DI
00844588000621
Brand
CS2 Acetabular Cup System
Company
CONSENSUS ORTHOPEDICS, INC.
Model
1004-1-2854
Catalog number
1004-1-2854
Device description
Acetabular Insert, 20° Hood
Published
2015-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00844588000621PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00844588000621008445880006218445880006210844588000621

GMDN Terms#

Term, Definition table
TermDefinition
Non-constrained polyethylene acetabular linerA sterile, implantable component of a two-piece acetabulum prosthesis that is inserted into an acetabular shell prosthesis to provide the articulating surface with a femoral head prosthesis as part of a total hip arthroplasty (THA). It is made of polyethylene (includes hylamer, cross-linked polyethylene), and does not include a stabilizing component to limit the range of motion of the hip.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter28Millimeter

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
Combination product
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00844588000379Consensus® Bone Screw0013-1-65150013-1-65152015-09-24
00844588000386Consensus® Bone Screw0013-1-65200013-1-65202015-09-24
00844588000393Consensus® Bone Screw0013-1-65250013-1-65252015-09-24
00844588000409Consensus® Bone Screw0013-1-65300013-1-65302015-09-24
00844588000416Consensus® Bone Screw0013-1-65350013-1-65352015-09-24
00844588000423Consensus® Bone Screw0013-1-65400013-1-65402015-09-24
00844588000430Consensus® Bone Screw0013-1-65450013-1-65452015-09-24
00844588000447Consensus® Bone Screw0013-1-65500013-1-65502015-09-24
00844588010262Consensus® Bone Screw0013-1-65550013-1-65552015-09-24
00844588010279Consensus® Bone Screw0013-1-65600013-1-65602015-09-24
00844588010286Consensus® Bone Screw0013-1-65650013-1-65652015-09-24
00844588000010Consensus® Hip System0006-0-28010006-0-28012015-09-24
00844588000027Consensus® Hip System0006-0-28020006-0-28022015-09-24
00844588000034Consensus® Hip System0006-0-28030006-0-28032015-09-24
00844588000041Consensus® Hip System0006-0-32010006-0-32012015-09-24
00844588000058Consensus® Hip System0006-0-32020006-0-32022015-09-24
00844588000065Consensus® Hip System0006-0-32030006-0-32032015-09-24
00844588000072Consensus® Hip System0007-1-22010007-1-22012015-09-24
00844588000089Consensus® Hip System0007-1-22020007-1-22022015-09-24
00844588000096Consensus® Hip System0007-1-22030007-1-22032015-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810030811992InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812036InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812043InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812050InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812067InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812074InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812081InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812098InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812104InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812111InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812128InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812135InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812142InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812159InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812173InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812180InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812197InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812203InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812210InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812227InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812234InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812241InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812258InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812265InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812272InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812289InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812296InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812319InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812326InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01
00810030812333InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLPH2026-06-01