FDA.reportPublic FDA data

Legion

Primary DI
00885556645659
Brand
Legion
Company
Smith & Nephew, Inc.
Model
71935413
Catalog number
71935413
Device description
LEGION FEM CONE ID 30MM RIGHT
Published
2017-01-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
MBHPROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerOrthopedic2
MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162775000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162775000Legion Cone SystemSmith & Nephew, Inc.2017-01-13JWH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885556645659PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885556645659008855566456598855566456590885556645659

GMDN Terms#

Term, Definition table
TermDefinition
Knee arthroplasty wedgeA sterile device designed to augment the implantation of a knee femur or tibia prosthesis by acting as a space-filler adjacent to the prosthesis, typically to replace lost bone. It is typically made of metal [e.g., cobalt-chrome (Co-Cr), cobalt-chrome-molybdenum (Co-Cr-Mo) or titanium (Ti)].

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
00885556819845Uni-CP Compression Plate286322ND286322ND2023-11-07
00885556819852Uni-CP Compression Plate286324ND286324ND2023-11-07
00885556819869Uni-CP Compression Plate286326ND286326ND2023-11-07
00885556819876Uni-CP Compression Plate286328ND286328ND2023-11-07
00885556819883Uni-CP Compression Plate286330ND286330ND2023-11-07
00885556819890Uni-CP Compression Plate286332ND286332ND2023-11-07
00885556819906Uni-CP Compression Plate286334ND286334ND2023-11-07
00885556819357General Instruments219865ND219865ND2023-10-27
00885556846599Total Wrist Fusion186200ND186200ND2023-10-27
00885556910245UNI-CP Compression Plate186300ND186300ND2023-10-27
00885556819722Total Wrist Fusion286220ND286220ND2023-10-26
00885556819746Total Wrist Fusion286222ND286222ND2023-10-26
00885556819760Total Wrist Fusion286224ND286224ND2023-10-26
00885556819807UNI-CP Compression Plate286314ND286314ND2023-10-26
00885556819814UNI-CP Compression Plate286316ND286316ND2023-10-26
00885556819821UNI-CP Compression Plate286318ND286318ND2023-10-26
00885556819838UNI-CP Compression Plate286320ND286320ND2023-10-26
00885556847329UNI-CP Compression Plate219535ND219535ND2023-10-26
00885556819623Total Wrist Fusion286210ND286210ND2023-10-25
00885556819647SURFIXTotal Wrist Fusion286212ND286212ND2023-10-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00192629005419ADVANCE®Microport Orthopedics Inc.MBH2026-09-18
00192629005419ADVANCE®Microport Orthopedics Inc.JWH2026-09-18
00192629005426ADVANCE®Microport Orthopedics Inc.MBH2026-09-18
00192629005426ADVANCE®Microport Orthopedics Inc.JWH2026-09-18
00192629005433ADVANCE®Microport Orthopedics Inc.JWH2026-09-18
00192629005440ADVANCE®Microport Orthopedics Inc.JWH2026-09-18
00192629005457ADVANCE®Microport Orthopedics Inc.JWH2026-09-18
00192629005464ADVANCE®Microport Orthopedics Inc.JWH2026-09-18
00192629005488ADVANCE®Microport Orthopedics Inc.MBH2026-09-18
00192629005488ADVANCE®Microport Orthopedics Inc.JWH2026-09-18
00192629005495ADVANCE®Microport Orthopedics Inc.MBH2026-09-18
00192629005495ADVANCE®Microport Orthopedics Inc.JWH2026-09-18
00192629005501ADVANCEMicroport Orthopedics Inc.JWH2026-09-18
00192629005501ADVANCEMicroport Orthopedics Inc.MBH2026-09-18
00192629005518ADVANCEMicroport Orthopedics Inc.MBH2026-09-18
00192629005518ADVANCEMicroport Orthopedics Inc.JWH2026-09-18
00192629005549ADVANCE®Microport Orthopedics Inc.JWH2026-09-18
00192629005556ADVANCE®Microport Orthopedics Inc.JWH2026-09-18
00192629005563ADVANCE®Microport Orthopedics Inc.JWH2026-09-18
00192629005570ADVANCE®Microport Orthopedics Inc.JWH2026-09-18
00192629082854EVOLUTIONMicroport Orthopedics Inc.JWH2026-09-18
00192629082861EVOLUTIONMicroport Orthopedics Inc.JWH2026-09-18
00192629082878EVOLUTIONMicroport Orthopedics Inc.JWH2026-09-18
00192629082885EVOLUTIONMicroport Orthopedics Inc.JWH2026-09-18
00192629082892EVOLUTIONMicroport Orthopedics Inc.JWH2026-09-18
00192629082908EVOLUTIONMicroport Orthopedics Inc.JWH2026-09-18
00192629082915EVOLUTIONMicroport Orthopedics Inc.JWH2026-09-18
00192629082922EVOLUTIONMicroport Orthopedics Inc.JWH2026-09-18
00192629082939EVOLUTIONMicroport Orthopedics Inc.JWH2026-09-18
00192629082946EVOLUTIONMicroport Orthopedics Inc.JWH2026-09-18