POLARCUP

Primary DI
27611996096570
Brand
POLARCUP
Company
Smith & Nephew, Inc.
Model
75017231
Catalog number
75017231
Device description
POLARCUP ANCHORING PEG (2 EACH)
Published
2015-08-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
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
K211176000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070278000POLARCUP DUAL MOBILITY SYSTEMPlus Orthopedics AG2007-04-16LPH
K211176000Smith & Nephew Hip SystemsSmith & Nephew, Inc.2022-07-01LPH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
27611996096570PrimaryGS10
07611996096576Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2761199609657027611996096570
07611996096576076119960965767611996096576

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw (non-sliding)A small, threaded, non-bioabsorbable, implantable rod intended to be used for internal orthopaedic fixation by being screwed into a limb bone, rib, the sternum and/or pelvis to hold a plate, nail, rod or prosthesis to the bone, or to provide direct interfragmentary stabilization of a fractured bone; it is not intended to be introduced through the sleeve of a femoral neck fixation plate/sleeve, or used in dentistry/orthodontics, craniofacial or spinal bones. It is typically of cortical or cancellous design and has a drive (e.g., a slot, or of cross, star, or polygonal shape) at its proximal end for introduction with a screwdriver. It is made of non-bioabsorbable materials (e.g., metal).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00: -
Special Storage Condition, Specify00Keep away from sunlight: -
Special Storage Condition, Specify00Keep dry: -

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)238-7538GUDID@SMITH-NEPHEW.COM

Regulatory Flags#

DUNS number
045483575
Device count
2
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
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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
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