FDA.reportPublic FDA data

POLARCUP

Primary DI
07611996096590
Brand
POLARCUP
Company
Smith & Nephew, Inc.
Model
75017232
Catalog number
75017232
Device description
POLARCUP CORTICAL SCREW 4.5X40 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
07611996096590PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07611996096590076119960965907611996096590

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
00885556918937NA72205810722058102026-08-19
00885556918968NA72205911722059112026-08-19
00885556919897NA72205802722058022026-08-19
00885556919965NA72205777722057772026-08-19
00885556919972NA72205778722057782026-08-19
00885556919989NA72205790722057902026-08-19
00885556919996NA72205791722057912026-08-19
00885556920008NA72205792722057922026-08-19
00885556920015NA72205793722057932026-08-19
00885556920022NA72205800722058002026-08-19
00885556920039NA72205801722058012026-08-19
00885556920046NA72205782722057822026-08-19
00885556920053NA72205803722058032026-08-19
00885556924433TESSA ACL FEM LIC NO CLOUD72205781722057812026-08-14
00885556924440TESSA72205783722057832026-08-14
00885556924457TESSA72205784722057842026-08-14
00885556924464NA72205785722057852026-08-14
00885556926680TESSA72205786722057862026-08-14
00885556926703TESSA72205787722057872026-08-14
00885556922170NA74034437740344372026-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00193982895006TRIVANCEGLOBUS MEDICAL, INC.KWY2026-08-14
00193982895013TRIVANCEGLOBUS MEDICAL, INC.KWY2026-08-14
00193982895020TRIVANCEGLOBUS MEDICAL, INC.KWY2026-08-14
00193982895037TRIVANCEGLOBUS MEDICAL, INC.KWY2026-08-14
00193982895044TRIVANCEGLOBUS MEDICAL, INC.KWY2026-08-14
00193982895051TRIVANCEGLOBUS MEDICAL, INC.KWY2026-08-14
00193982895068TRIVANCEGLOBUS MEDICAL, INC.KWY2026-08-14
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
00193982895167TRIVANCEGLOBUS MEDICAL, INC.KWY2026-08-14
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