FDA.reportPublic FDA data

Polar

Primary DI
00885556913987
Brand
Polar
Company
Smith & Nephew, Inc.
Model
E0018186-2
Catalog number
E0018186-2
Device description
POLAR CALCAR PLANER - 45MM
Published
2023-10-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JDGProsthesis, hip, femoral component, cemented, metal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDGProsthesis, Hip, Femoral Component, Cemented, MetalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123598000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123598000SMITH & NEPHEW, INC. HIP SYSTEM INSTRUMENTATIONSmith & Nephew, Inc.2013-06-28JDI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885556913987PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885556913987008855569139878855569139870885556913987

GMDN Terms#

Term, Definition table
TermDefinition
Bone-resection orthopaedic reamer, reusableAn orthopaedic surgical instrument intended to resect bone (cut out part of the bone), and in some cases hypertrophic tissue [e.g., ligamentum flavum], to: 1) accept a prosthetic implant, typically at or within a joint (e.g., condyle of knee, neck of humerus, olecranon of ulna); and/or 2) relieve pressure at or facilitate access to a joint. Commonly called a mill or a reamer, it is typically designed as a stainless steel cylindrical body with an end/circumferential cutting edge and is attached to a shaft for manual or powered rotation. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
045483575
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00885556833933Salto Talaris Total Ankle ProsthesisMJU952TMJU952T2022-12-22
00885556833940Salto Talaris Total Ankle ProsthesisMJU953TMJU953T2022-12-22
00885556833957Salto Talaris Total Ankle ProsthesisMJV219TMJV219T2022-12-22
00885556833964Salto Talaris Total Ankle ProsthesisMJV220TMJV220T2022-12-22
00885556833971Salto Talaris Total Ankle ProsthesisMJV221TMJV221T2022-12-22
00885556833988Salto Talaris Total Ankle ProsthesisMJV229TMJV229T2022-12-22
00885556834237Silicone Toe SystemCGT-205TCGT-205T2022-12-22
00885556834251Silicone Toe SystemCGT-305TCGT-305T2022-12-22
00885556834299Silicone Toe SystemCGT-505TCGT-505T2022-12-22
00885556835029Ti6 Internal Fixation SystemDS1007DS10072022-12-22
00885556835203Surgical InstrumentsFS-1006FS-10062022-12-22
00885556836187Ti6 Internal Fixation SystemTH3018TH30182022-12-22
00885556837856Total Foot System 2220425022042502022-12-22
00885556838785Total Foot System 2282302728230272022-12-21
00885556841631XT Revision Ankle Replacement SystemMJU984TMJU984T2022-12-21
00885556841778XT Revision Ankle Replacement SystemMJV222TMJV222T2022-12-21
00885556841785XT Revision Ankle Replacement SystemMJV223TMJV223T2022-12-21
00885556854921Freedom Wrist Arthroplasty System3480473480472022-12-22
00885556856680Surgical InstrumentsEXT-200-00EXT-200-002022-12-22
00885556860168Titan Modular Shoulder System 2.5DRL-0923-047-001DRL-0923-047-0012022-12-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327383386ExeterHowmedica Osteonics Corp.JDG2022-11-30
07613327383430ExeterHowmedica Osteonics Corp.JDG2022-11-30
07613327383454ExeterHowmedica Osteonics Corp.JDG2022-11-30
07613327383461ExeterHowmedica Osteonics Corp.JDG2022-11-30
07613327383485ExeterHowmedica Osteonics Corp.JDG2022-11-30
07613327383515ExeterHowmedica Osteonics Corp.JDG2022-11-30
07613327383522ExeterHowmedica Osteonics Corp.JDG2022-11-30
07613327383553ExeterHowmedica Osteonics Corp.JDG2022-11-30
07613327383591ExeterHowmedica Osteonics Corp.JDG2022-11-30
07613327383614ExeterHowmedica Osteonics Corp.JDG2022-11-30
07613327383621ExeterHowmedica Osteonics Corp.JDG2022-11-30
07613327383676ExeterHowmedica Osteonics Corp.JDG2022-11-30
07613327383706ExeterHowmedica Osteonics Corp.JDG2022-11-30
07613327383713ExeterHowmedica Osteonics Corp.JDG2022-11-30
07613327383737ExeterHowmedica Osteonics Corp.JDG2022-11-30
07613327383744ExeterHowmedica Osteonics Corp.JDG2022-11-30
07613327383751ExeterHowmedica Osteonics Corp.JDG2022-11-30
07613327383805ExeterHowmedica Osteonics Corp.JDG2022-11-30
07613327383812ExeterHowmedica Osteonics Corp.JDG2022-11-30
07613327383836ExeterHowmedica Osteonics Corp.JDG2022-11-30
07613327383843ExeterHowmedica Osteonics Corp.JDG2022-11-30
07613327383904ExeterHowmedica Osteonics Corp.JDG2022-11-30
07613327383911ExeterHowmedica Osteonics Corp.JDG2022-11-30
07613327123852V40Howmedica Osteonics Corp.JDG2018-06-13
07613327123739EXETERHowmedica Osteonics Corp.JDG2018-05-03
07613327123746EXETERHowmedica Osteonics Corp.JDG2018-05-03
07613327123753EXETERHowmedica Osteonics Corp.JDG2018-05-03
07613327123777EXETERHowmedica Osteonics Corp.JDG2018-05-03
07613327123791EXETERHowmedica Osteonics Corp.JDG2018-05-03
07613327123845EXETERHowmedica Osteonics Corp.JDG2018-05-03