FDA.reportPublic FDA data

Legion

Primary DI
00885556804742
Brand
Legion
Company
Smith & Nephew, Inc.
Model
E0017314-1
Catalog number
E0017314-1
Device description
FEMORAL STYLUS
Published
2021-03-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HRYPROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRYProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/PolymerOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885556804742PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885556804742008855568047428855568047420885556804742

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic reamer guideAn orthopaedic surgical device that functions as a guide for an orthopaedic reamer. The guide, commonly called a spigot, is inserted into a predetermined site where bone is to be resected for the acceptance of a prosthetic implant, typically at or within a joint (e.g., the condyle head of the knee, the olecranon of the ulna) or for the reaming of the intramedullary canal for acceptance of an intramedullary nail. The device allows the controlled cutting action of the reamer which is steered down its length. It is typically made of a high-grade stainless steel alloy; it comes in varying sizes. 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
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03596010479235ECHELON71342011713420112015-09-28
03596010479266ECHELON71342014713420142015-09-28
03596010479273ECHELON71342015713420152015-09-28
03596010479297ECHELON71342017713420172015-09-28
03596010479303ECHELON71342018713420182015-09-28
03596010479310ECHELON71342019713420192015-09-28
03596010479341ECHELON71343012713430122015-09-28
03596010459749SYNERGY71309109713091092015-08-30
03596010459756SYNERGY71309110713091102015-08-30
03596010459787SYNERGY71309113713091132015-08-30
03596010459794SYNERGY71309114713091142015-08-30
03596010459817SYNERGY71309116713091162015-08-30
03596010459831SYNERGY71309118713091182015-08-30
03596010479259ECHELON71342013713420132015-09-28
03596010479280ECHELON71342016713420162015-09-28
03596010479358ECHELON71343013713430132015-09-28
03596010479365ECHELON71343014713430142015-09-28
03596010479389ECHELON71343016713430162015-09-28
03596010479396ECHELON71343017713430172015-09-28
03596010479402ECHELON71343018713430182015-09-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07613327127508INSTRUMENTHowmedica Osteonics Corp.HRY2017-11-24
07613327127539INSTRUMENTHowmedica Osteonics Corp.HRY2017-11-24
07613327127560INSTRUMENTHowmedica Osteonics Corp.HRY2017-11-24
07613327127607INSTRUMENTHowmedica Osteonics Corp.HRY2017-11-24
07613154557431INSTRUMENTHowmedica Osteonics Corp.HRY2016-09-24
07613327051094INSTRUMENTHowmedica Osteonics Corp.HRY2016-09-24
07613327051100INSTRUMENTHowmedica Osteonics Corp.HRY2016-09-24
07613327051117INSTRUMENTHowmedica Osteonics Corp.HRY2016-09-24
07613327051124INSTRUMENTHowmedica Osteonics Corp.HRY2016-09-24
07613327051131INSTRUMENTHowmedica Osteonics Corp.HRY2016-09-24
07613327051148INSTRUMENTHowmedica Osteonics Corp.HRY2016-09-24
07613327051155INSTRUMENTHowmedica Osteonics Corp.HRY2016-09-24
07613327051162INSTRUMENTHowmedica Osteonics Corp.HRY2016-09-24
07613327051179INSTRUMENTHowmedica Osteonics Corp.HRY2016-09-24
07613327051186INSTRUMENTHowmedica Osteonics Corp.HRY2016-09-24
07613327051193INSTRUMENTHowmedica Osteonics Corp.HRY2016-09-24
07613327051209INSTRUMENTHowmedica Osteonics Corp.HRY2016-09-24
07613327051216INSTRUMENTHowmedica Osteonics Corp.HRY2016-09-24
07613327051223INSTRUMENTHowmedica Osteonics Corp.HRY2016-09-24
07613327051230INSTRUMENTHowmedica Osteonics Corp.HRY2016-09-24
07613327051247INSTRUMENTHowmedica Osteonics Corp.HRY2016-09-24
07613327127546INSTRUMENTHowmedica Osteonics Corp.HRY2016-09-24
07613327127553INSTRUMENTHowmedica Osteonics Corp.HRY2016-09-24
07613327127577INSTRUMENTHowmedica Osteonics Corp.HRY2016-09-24
07613327127584INSTRUMENTHowmedica Osteonics Corp.HRY2016-09-24