FDA.reportPublic FDA data

Legion

Primary DI
00885556886908
Brand
Legion
Company
Smith & Nephew, Inc.
Model
E0017843-4
Catalog number
E0017843-4
Device description
TIBIAL BASEPLATE TRIAL SZ 4 LT W/ BOSS
Published
2022-10-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
00885556886908PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885556886908008855568869088855568869080885556886908

GMDN Terms#

Term, Definition table
TermDefinition
Knee tibia prosthesis trial, reusableA copy of a final tibia 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 femur trial prosthesis and a patella trial prosthesis. It is typically made of metal or polymer material and includes tibial base plate trials, tibial spacer trials, tibial insert trials, tibial stem trials, tibial wedge/augment trials, and guide pin trials. 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
109903521
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00885556919712Real IntelligenceROB30001ROB300012026-03-10
00885556919729Real IntelligenceROB30002ROB300022026-03-10
00885556919743Real IntelligenceROB30003ROB300032026-03-10
00885556919750Real IntelligenceROB30004ROB300042026-03-10
00885556919767Real IntelligenceROB30005ROB300052026-03-10
00885556919774Real IntelligenceROB30006ROB300062026-03-10
00885556924198Real IntelligenceROB30026ROB300262026-03-10
00885556924204Real IntelligenceROB30021ROB300212026-03-10
00885556924211Real IntelligenceROB30027ROB300272026-03-10
00885556924228Real IntelligenceROB30022ROB300222026-03-10
00885556924235Real IntelligenceROB30023ROB300232026-03-10
00885556924242Real IntelligenceROB30024ROB300242026-03-10
00885556924266Real IntelligenceROB30028ROB300282026-03-10
00885556924273Real IntelligenceROB30020ROB300202026-03-10
00885556924297Real IntelligenceROB30880ROB308802026-03-10
20885556924307NAROB30031ROB300312026-03-10
00885556787786NA74034136740341362026-02-20
00885556884027NA74038834740388342026-02-20
00885556884034NA74038835740388352026-02-20
00885556884140NA74038846740388462026-02-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00811767027779FREEDOM PARTIAL KNEEMAXX ORTHOPEDICS, INC.HRY2025-07-31
00811767027786FREEDOM PARTIAL KNEEMAXX ORTHOPEDICS, INC.HRY2025-07-31
00811767027793FREEDOM PARTIAL KNEEMAXX ORTHOPEDICS, INC.HRY2025-07-31
00811767027809FREEDOM PARTIAL KNEEMAXX ORTHOPEDICS, INC.HRY2025-07-31
08033390281751PHYSICA POROUS CR - CoCrMo + PoroTiLIMACORPORATE SPAHRY2025-07-09
08033390281775PHYSICA POROUS CR - CoCrMo + PoroTiLIMACORPORATE SPAHRY2025-07-09
08033390281782PHYSICA POROUS CR - CoCrMo + PoroTiLIMACORPORATE SPAHRY2025-07-09
08033390281799PHYSICA POROUS CR - CoCrMo + PoroTiLIMACORPORATE SPAHRY2025-07-09
08033390281904PHYSICA POROUS CR - CoCrMo + PoroTiLIMACORPORATE SPAHRY2025-07-09
08033390281911PHYSICA POROUS CR - CoCrMo + PoroTiLIMACORPORATE SPAHRY2025-07-09
08033390281928PHYSICA POROUS CR - CoCrMo + PoroTiLIMACORPORATE SPAHRY2025-07-09
08033390281935PHYSICA POROUS CR - CoCrMo + PoroTiLIMACORPORATE SPAHRY2025-07-09
08033390281942PHYSICA POROUS CR - CoCrMo + PoroTiLIMACORPORATE SPAHRY2025-07-09
08033390281959PHYSICA POROUS CR - CoCrMo + PoroTiLIMACORPORATE SPAHRY2025-07-09
08033390281966PHYSICA POROUS CR - CoCrMo + PoroTiLIMACORPORATE SPAHRY2025-07-09
08033390281973PHYSICA POROUS CR - CoCrMo + PoroTiLIMACORPORATE SPAHRY2025-07-09
08033390281980PHYSICA POROUS CR - CoCrMo + PoroTiLIMACORPORATE SPAHRY2025-07-09
08033390281997PHYSICA POROUS CR - CoCrMo + PoroTiLIMACORPORATE SPAHRY2025-07-09
08033390282000PHYSICA POROUS CR - CoCrMo + PoroTiLIMACORPORATE SPAHRY2025-07-09
08033390282024PHYSICA POROUS CR - CoCrMo + PoroTiLIMACORPORATE SPAHRY2025-07-09
08033390282048PHYSICA POROUS CR - CoCrMo + PoroTiLIMACORPORATE SPAHRY2025-07-09
08033390282055PHYSICA POROUS CR - CoCrMo + PoroTiLIMACORPORATE SPAHRY2025-07-09
08033390282062PHYSICA POROUS CR - CoCrMo + PoroTiLIMACORPORATE SPAHRY2025-07-09
08033390282079PHYSICA POROUS CR - CoCrMo + PoroTiLIMACORPORATE SPAHRY2025-07-09
04026575448630LinkSymphoKneeWALDEMAR LINK GmbH & Co. KGHRY2025-04-02
04026575448647LinkSymphoKneeWALDEMAR LINK GmbH & Co. KGHRY2025-04-02
00885556921388LegionSmith & Nephew, Inc.HRY2024-11-26
00885556921395LegionSmith & Nephew, Inc.HRY2024-11-26
00885556921401LegionSmith & Nephew, Inc.HRY2024-11-26
00885556921418LegionSmith & Nephew, Inc.HRY2024-11-26