POLARCUPTM

Primary DI
07611996096163
Brand
POLARCUPTM
Company
Smith & Nephew, Inc.
Model
75017193
Catalog number
75017193
Device description
POLARCUP SHELL TI-PLASMA 67 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
07611996096163PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07611996096163076119960961637611996096163

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
00885554009101NA720770572077052015-08-30
00885556925690NAROB30080ROB300802026-06-04
03596010589101JOURNEY71422274714222742015-08-30
03596010589132JOURNEY71422277714222772015-08-30
03596010000675OXINIUM71343603713436032015-08-30
03596010474148OXINIUM71342800713428002015-08-30
03596010474162OXINIUM71342804713428042015-08-30
03596010474179OXINIUM71342808713428082015-08-30
03596010474209OXINIUM71343200713432002015-08-30
03596010474216OXINIUM71343203713432032015-08-30
03596010474223OXINIUM71343204713432042015-08-30
03596010474230OXINIUM71343208713432082015-08-30
03596010477279OXINIUM71343600713436002015-08-30
03596010477286OXINIUM71343604713436042015-08-30
03596010477293OXINIUM71343608713436082015-08-30
03596010488862OXINIUM71342200713422002015-08-30
03596010544193JOURNEY71461012714610122015-08-30
03596010544209JOURNEY71461013714610132015-08-30
03596010544216JOURNEY71461014714610142015-08-30
03596010544223JOURNEY71461015714610152015-08-30

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