FDA.reportPublic FDA data

LEGION

Primary DI
00885556109151
Brand
LEGION
Company
Smith & Nephew, Inc.
Model
71421302
Catalog number
71421302
Device description
LEGION HINGE TIBIAL BASEPLATE SIZE 2 LEFT
Published
2015-08-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KROPROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KROProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K081111000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K081111000LEGION HINGE KNEE SYSTEMSmith & Nephew, Inc.2008-07-23KRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885556109151PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885556109151008855561091518855561091510885556109151

GMDN Terms#

Term, Definition table
TermDefinition
Uncoated knee tibia prosthesis, metallicAn implantable device designed to replace the tibial condyles (tibial component) during primary bicondylar replacement of the knee joint, femoral bone resection, or to replace a dysfunctional knee prosthesis (revision); it is made of metal [e.g., cobalt-chrome (Co-Cr), cobalt-chrome-molybdenum (Co-Cr-Mo), titanium (Ti)] and is not coated with a material intended to improve fixation and stability by promoting bone ingrowth. The device is designed to articulate with an insert and/or the femoral prosthetic component of the knee joint and its implantation is intended to be performed with bone cement.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+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
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
00885556859742Titan Modular Shoulder SystemCSA-0920-20CSA-0920-202026-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B278AM25002200C0ELEOS™ Limb Salvage System with NanoCept® TechnologyONKOS SURGICAL, INC.KRO2026-06-09
10603295529712ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529729ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529736ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529743ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529750ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529767ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529774ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529781ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529798ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529804ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529811ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529828ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529835ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529842ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529859ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529866ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529873ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529880ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529897ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529903ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529910ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529927ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529934ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529941ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529958ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529965ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529972ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529989ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529996ATTUNEDEPUY (IRELAND)KRO2025-10-31