FDA.reportPublic FDA data

Acetabular Shell

Primary DI
00840286800020
Brand
Acetabular Shell
Company
Shalby Advanced Technologies, Inc.
Model
1701-0-0046
Catalog number
1701-0-0046
Device description
CHS, CS2, Acetabular Shell, Ti, Ti Plasma, Hemispherical, 3-Hole, 46mm
Published
2021-12-15
Public version status
New
Distribution status
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
00840286800020PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840286800020008402868000208402868000200840286800020

GMDN Terms#

Term, Definition table
TermDefinition
Acetabular shellAn 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#

Type, Value, Unit table
TypeValueUnit
Outer Diameter46Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(916)355-7100khansen@consensusortho.com

Regulatory Flags#

DUNS number
085976260
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
00840286841597Consensus Hip System/UniSyn Hip System4410-10020-A4410-10020-A2025-05-22
00840286841962Consensus Hip System1800-0-08401800-0-08402025-05-22
00840286843034Consensus Knee System/Revision Knee System2800-0-07052800-0-07052025-05-22
00840286847162Tahoe Unicompartmental Knee System3000-0-00793000-0-00792025-05-22
00840286847650Tahoe Unicompartmental Knee System3000-0-00733000-0-00732025-05-22
00840286847728Tahoe Unicompartmental Knee System3000-0-00613000-0-00612025-05-22
00840286853897Consensus Hip System1800-0-08451800-0-08452025-05-22
00840286855105Consensus Knee System/Revision Knee System2800-0-07062800-0-07062025-05-22
00840286855112Consensus Knee System/Revision Knee System2800-0-07072800-0-07072025-05-22
00840286855129Consensus Knee System/Revision Knee System2800-0-07082800-0-07082025-05-22
00840286855174CS2 Acetabular System1800-0-15221800-0-15222025-05-22
00840286840958TaperSet Hip System1910-0-00101910-0-00102025-05-21
00840286840996TaperSet Hip System1910-1-00121910-1-00122025-05-21
00840286845182Consensus Knee System2800-0-29502800-0-29502025-05-21
00840286845588Consensus Knee System2800-1-08002800-1-08002025-05-21
00840286840989Revision Knee System/TaperSet Hip System/Consensus Hip System/UniSyn Hip System4410-20070-A4410-20070-A2025-05-14
00840286843959UniSyn Hip System4410-20031-A4410-20031-A2025-05-14
00840286855082Consensus Knee System/Revision Knee System2800-0-07012800-0-07012025-05-14
00840286855099Consensus Knee System/Revision Knee System2800-0-07022800-0-07022025-05-14
00840286855228CS2 Acetabular System1800-0-15281800-0-15282025-05-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07611996098075POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996098082POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996098099POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996098105POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996098112POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996098129POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996098136POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996098143POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996098150POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996098174POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996098501POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996098518POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996098525POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996098532POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996111323POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996111330POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996111354POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996111378POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996111392POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996111408POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996111415POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996111422POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996111446POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996111514POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996111538POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996111552POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996112320POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996112351POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996112368POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996114638POLARCUPSmith & Nephew, Inc.LPH2015-11-25