FDA.reportPublic FDA data

POLARCUP

Primary DI
07611996096606
Brand
POLARCUP
Company
Smith & Nephew, Inc.
Model
75017233
Catalog number
75017233
Device description
POLARCUP CORTICAL SCREW 4.5X44 NON CEM
Published
2015-08-29
Public version status
Update
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
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
07611996096606PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07611996096606076119960966067611996096606

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw, non-bioabsorbable, sterileA small, sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). There are a number of kinds available: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A "lag screw" can be any of these used to obtain compression across bone fragments.

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
00885556925171REAL INTELLIGENCEROB100021FROB100021F2026-07-30
00885556925188REAL INTELLIGENCEROB100022FROB100022F2026-07-30
00885556919743Real IntelligenceROB30003ROB300032026-03-10
00885556919767Real IntelligenceROB30005ROB300052026-03-10
20885556628908NavioPFSDV0016PFSDV00162016-09-21
00885556820964General InstrumentsMA3511NDMA3511ND2023-10-27
00885556822722Capture High Torque Screw SystemMAT-000-02MAT-000-022022-12-21
00885556822937Total Foot System 23210103210102022-12-21
00885556822944Total Foot System 23210123210122022-12-21
00885556828090XT Revision Ankle Replacement SystemMJV551TMJV551T2022-12-21
00885556832431Salto Talaris Total Ankle ProsthesisMJU012TMJU012T2022-12-21
00885556837825Total Foot System 23820003820002022-12-22
00885556840375Total Wrist Fusion System3035113035112022-12-21
00885556841525XT Revision Ankle Replacement SystemMJU944TMJU944T2022-12-21
00885556855003Freedom Wrist Arthroplasty System3480593480592022-12-22
00885556858301PyroCarbon PIP Total Joint SystemOSG-200-00OSG-200-002022-12-22
00885556858325PyroCarbon PIP Total Joint SystemOSG-200-10PVOSG-200-10PV2022-12-22
00885556858349PyroCarbon PIP Total Joint SystemOSG-200-20PVOSG-200-20PV2022-12-22
00885556858363PyroCarbon PIP Total Joint SystemOSG-200-30PVOSG-200-30PV2022-12-22
00885556858387PyroCarbon PIP Total Joint SystemOSG-200-40PVOSG-200-40PV2022-12-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00193982895006TRIVANCEGLOBUS MEDICAL, INC.KWY2026-08-14
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00193982895075TRIVANCEGLOBUS MEDICAL, INC.KWY2026-08-14
00193982895082TRIVANCEGLOBUS MEDICAL, INC.KWY2026-08-14
00193982895099TRIVANCEGLOBUS MEDICAL, INC.KWY2026-08-14
00193982895105TRIVANCEGLOBUS MEDICAL, INC.KWY2026-08-14
00193982895112TRIVANCEGLOBUS MEDICAL, INC.KWY2026-08-14
00193982895136TRIVANCEGLOBUS MEDICAL, INC.KWY2026-08-14
00193982895143TRIVANCEGLOBUS MEDICAL, INC.KWY2026-08-14
00193982895150TRIVANCEGLOBUS MEDICAL, INC.KWY2026-08-14
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00193982895174TRIVANCEGLOBUS MEDICAL, INC.KWY2026-08-14
00193982895181TRIVANCEGLOBUS MEDICAL, INC.KWY2026-08-14
00193982895198TRIVANCEGLOBUS MEDICAL, INC.KWY2026-08-14
00193982895204TRIVANCEGLOBUS MEDICAL, INC.KWY2026-08-14
00193982895211TRIVANCEGLOBUS MEDICAL, INC.KWY2026-08-14
00193982895228TRIVANCEGLOBUS MEDICAL, INC.KWY2026-08-14
00193982895235TRIVANCEGLOBUS MEDICAL, INC.KWY2026-08-14
00193982895242TRIVANCEGLOBUS MEDICAL, INC.KWY2026-08-14
00193982895266TRIVANCEGLOBUS MEDICAL, INC.KWY2026-08-14
00193982895273TRIVANCEGLOBUS MEDICAL, INC.KWY2026-08-14
00193982895280TRIVANCEGLOBUS MEDICAL, INC.KWY2026-08-14
00193982895297TRIVANCEGLOBUS MEDICAL, INC.KWY2026-08-14
00193982895303TRIVANCEGLOBUS MEDICAL, INC.KWY2026-08-14
00193982895310TRIVANCEGLOBUS MEDICAL, INC.KWY2026-08-14