POLARCUPTM

Primary DI
07611996096040
Brand
POLARCUPTM
Company
Smith & Nephew, Inc.
Model
75017181
Catalog number
75017181
Device description
POLARCUP SHELL TI-PLASMA 43 NON-CEM
Published
2015-08-29
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
KWYProsthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or UncementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K070278000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070278000POLARCUP DUAL MOBILITY SYSTEMPlus Orthopedics AG2007-04-16LPH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07611996096040PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07611996096040076119960960407611996096040

GMDN Terms#

Term, Definition table
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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)821-5700gudid@smith-nephew.com
+1(800)238-7538GUDID@SMITH-NEPHEW.COM

Regulatory Flags#

DUNS number
045483575
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00885556925379CORIOGRAPHROB20032ROB200322026-07-08
00885556925386CORIOGRAPHROB20031ROB200312026-07-08
00885556904879EVOS70887105708871052026-06-25
00885556904923EVOS70897130708971302026-06-25
00885556906163EVOS70879090708790902026-06-25
00885556906170EVOS70879095708790952026-06-25
00885556906187EVOS70879100708791002026-06-25
00885556906194EVOS70879105708791052026-06-25
00885556906200EVOS70879110708791102026-06-25
00885556906217EVOS70879115708791152026-06-25
00885556906224EVOS70879120708791202026-06-25
00885556906231EVOS70879125708791252026-06-25
00885556906248EVOS70879130708791302026-06-25
00885556906255EVOS70879135708791352026-06-25
00885556906262EVOS70879140708791402026-06-25
00885556906279EVOS70879145708791452026-06-25
00885556906286EVOS70879150708791502026-06-25
00885556906293EVOS70879155708791552026-06-25
00885556906309EVOS70879160708791602026-06-25
00885556906316EVOS70879165708791652026-06-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850011453476REMEDY CoCr Modular HeadsOSTEOREMEDIES, LLCKWY2026-06-01
00850011453483REMEDY CoCr Modular HeadsOSTEOREMEDIES, LLCKWY2026-06-01
00850011453490REMEDY CoCr Modular HeadsOSTEOREMEDIES, LLCKWY2026-06-01
00850011453506REMEDY Poly+Plus Acetabular CupOSTEOREMEDIES, LLCKWY2026-06-01
00850011453513REMEDY Poly+Plus Acetabular CupOSTEOREMEDIES, LLCKWY2026-06-01
00850011453520REMEDY Poly+Plus Acetabular CupOSTEOREMEDIES, LLCKWY2026-06-01
07611996118674POLARSTEMSmith & Nephew, Inc.KWY2017-01-12
07611996142327POLARSTEMSmith & Nephew, Inc.KWY2017-01-12
07611996142334POLARSTEMSmith & Nephew, Inc.KWY2017-01-12
07611996142341POLARSTEMSmith & Nephew, Inc.KWY2017-01-12
07611996142358POLARSTEMSmith & Nephew, Inc.KWY2017-01-12
07611996142365POLARSTEMSmith & Nephew, Inc.KWY2017-01-12
07611996142372POLARSTEMSmith & Nephew, Inc.KWY2017-01-12
07611996142389POLARSTEMSmith & Nephew, Inc.KWY2017-01-12
07611996074901SL-PLUSSmith & Nephew, Inc.KWY2016-08-19
07611996074918SL-PLUSSmith & Nephew, Inc.KWY2016-08-19
07611996074925SL-PLUSSmith & Nephew, Inc.KWY2016-08-19
07611996074932SL-PLUSSmith & Nephew, Inc.KWY2016-08-19
07611996074949SL-PLUSSmith & Nephew, Inc.KWY2016-08-19
07611996074956SL-PLUSSmith & Nephew, Inc.KWY2016-08-19
07611996074963SL-PLUSSmith & Nephew, Inc.KWY2016-08-19
07611996074987SL-PLUSSmith & Nephew, Inc.KWY2016-08-19
07611996074994SL-PLUSSmith & Nephew, Inc.KWY2016-08-19
07611996075014SL-PLUSSmith & Nephew, Inc.KWY2016-08-19
07611996075021SL-PLUSSmith & Nephew, Inc.KWY2016-08-19
07611996095586SLR-PLUSSmith & Nephew, Inc.KWY2016-08-19
07611996095593SLR-PLUSSmith & Nephew, Inc.KWY2016-08-19
07611996095616SLR-PLUSSmith & Nephew, Inc.KWY2016-08-19
07611996095630SLR-PLUSSmith & Nephew, Inc.KWY2016-08-19
07611996095647SLR-PLUSSmith & Nephew, Inc.KWY2016-08-19