FDA.reportPublic FDA data

LEGION

Primary DI
00885556234501
Brand
LEGION
Company
Smith & Nephew, Inc.
Model
71434153
Catalog number
71434153
Device description
LEGION NARROW REAM THROUGH TRIAL SIZE 3N RIGHT
Published
2015-08-30
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
JWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K112941000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112941000LEGION NARROW OXINIUM CRUCIATE RETAINING AND POSTERIOR STABILIZED FENORAL COMPONENTSSmith & Nephew, Inc.2011-12-20JWH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885556234501PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885556234501008855562345018855562345010885556234501

GMDN Terms#

Term, Definition table
TermDefinition
Knee femur prosthesis trialA copy of a final femur prosthesis designed to be used during unicompartmental knee replacement surgery or total knee arthroplasty (TKA) to determine the correct alignment, size, and fit of the final prosthesis. It is one of a set, or a set, of graduated sizes, and may be used in conjunction with a knee tibia trial prosthesis and a patella trial prosthesis. It is typically made of metal or polymer material and includes femoral articulation trials, femoral spacer trials, femoral wedge/augment trials, anterior stop trials, stem adaptor trials, and stem trials. This is a reusable device intended to be sterilized prior to use.

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
00885556838211Total Foot System 2280500728050072023-04-18
03596010619952NA72201597722015972015-08-29
03596010619969NA72201598722015982015-08-29
00885556572351NA72201597S72201597S2017-06-15
00885556572368NA72201598S72201598S2017-06-15
00885556830543PyroCarbon Modular Radial HeadTRL-310-01TRL-310-012026-09-24
00885556830550PyroCarbon Modular Radial HeadTRL-310-02TRL-310-022026-09-24
00885556830567PyroCarbon Modular Radial HeadTRL-310-03TRL-310-032026-09-24
00885556830574PyroCarbon Modular Radial HeadTRL-310-04TRL-310-042026-09-24
00885556839690Total Foot System 2CSA-800-06CSA-800-062026-09-24
00885556839706Total Foot System 2CSA-800-07CSA-800-072026-09-24
00885556854778Cadence Total Ankle SystemCSA-1020-0014CSA-1020-00142026-09-24
00885556859636Titan Modular Shoulder SystemCSA092009CSA0920092026-09-24
00885556859643Titan Modular Shoulder SystemCSA092010CSA0920102026-09-24
00885556859650Titan Modular Shoulder SystemCSA092011CSA0920112026-09-24
00885556859698Titan Modular Shoulder SystemCSA-0920-15CSA-0920-152026-09-24
00885556859704Titan Modular Shoulder SystemCSA-0920-16CSA-0920-162026-09-24
00885556859711Titan Modular Shoulder SystemCSA-0920-17CSA-0920-172026-09-24
00885556859728Titan Modular Shoulder SystemCSA-0920-18CSA-0920-182026-09-24
00885556859735Titan Modular Shoulder SystemCSA-0920-19CSA-0920-192026-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08906067247292Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
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08906067247322Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
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08906067247360Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
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08906067247391Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247407Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247414Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247421Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247438Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247445Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247452Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247469Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247476Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247483Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247490Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247506Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247513Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247520Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05
08906067247537Opulent TiNbN Coated KneeMERIL HEALTHCARE PRIVATE LIMITEDJWH2026-10-05