FDA.reportPublic FDA data

ECHELON

Primary DI
03596010328656
Brand
ECHELON
Company
Smith & Nephew, Inc.
Model
71310616
Catalog number
71310616
Device description
ECHELON CEMENTED FEM COMP 30MM CALCAR SZ 16 175MM
Published
2015-08-30
Public version status
Update
Distribution status
Not 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
JDIProsthesis, hip, semi-constrained, metal/polymer, cemented
LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, CementedOrthopedic2
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K963486000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K963486000REVISION HIP SYSTEMSmith & Nephew Richards, Inc.1996-11-27JDI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03596010328656PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03596010328656035960103286563596010328656

GMDN Terms#

Term, Definition table
TermDefinition
Uncoated hip femur prosthesis, modularA sterile implantable principal component of a total hip prosthesis (femoral component) typically designed to replace the femoral head and neck; the device is composed of two or more separate pieces (e.g., head, neck, and stem) designed to be joined and is not coated with materials intended to improve fixation and stability by promoting bone ingrowth. The device may be made of metal and/or ceramic materials. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation is intended to be performed with bone cement.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)821-5700gudid@smith-nephew.com
+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
00885556918937NA72205810722058102026-08-19
00885556918968NA72205911722059112026-08-19
00885556919897NA72205802722058022026-08-19
00885556919965NA72205777722057772026-08-19
00885556919972NA72205778722057782026-08-19
00885556919989NA72205790722057902026-08-19
00885556919996NA72205791722057912026-08-19
00885556920008NA72205792722057922026-08-19
00885556920015NA72205793722057932026-08-19
00885556920022NA72205800722058002026-08-19
00885556920039NA72205801722058012026-08-19
00885556920046NA72205782722057822026-08-19
00885556920053NA72205803722058032026-08-19
00885556924433TESSA ACL FEM LIC NO CLOUD72205781722057812026-08-14
00885556924440TESSA72205783722057832026-08-14
00885556924457TESSA72205784722057842026-08-14
00885556924464NA72205785722057852026-08-14
00885556926680TESSA72205786722057862026-08-14
00885556926703TESSA72205787722057872026-08-14
00885556922170NA74034437740344372026-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840097536675Velora Acetabular System InstrumentationRestor3d, Inc.LPH2026-08-19
00192629031999LineageMicroport Orthopedics Inc.LPH2026-08-18
00192629032071LineageMicroport Orthopedics Inc.JDI2026-08-18
00192629080515MICROPORTMicroport Orthopedics Inc.LPH2026-08-18
00192629176553MICROPORTMicroport Orthopedics Inc.LPH2026-08-18
00192629031937LineageMicroport Orthopedics Inc.JDI2026-08-17
00192629031951MICROPORTMicroport Orthopedics Inc.LPH2026-08-17
00192629031968LineageMicroport Orthopedics Inc.LPH2026-08-17
00192629031975LineageMicroport Orthopedics Inc.LPH2026-08-17
00192629031982LineageMicroport Orthopedics Inc.LPH2026-08-17
00192629163584MICROPORTMicroport Orthopedics Inc.LPH2026-08-17
00192629176515MICROPORTMicroport Orthopedics Inc.LPH2026-08-17
00192629176522MICROPORTMicroport Orthopedics Inc.LPH2026-08-17
00192629176539MICROPORTMicroport Orthopedics Inc.LPH2026-08-17
00192629176546MICROPORTMicroport Orthopedics Inc.LPH2026-08-17
00193982895006TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895006TRIVANCEGLOBUS MEDICAL, INC.LPH2026-08-14
00193982895013TRIVANCEGLOBUS MEDICAL, INC.LPH2026-08-14
00193982895013TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895020TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895020TRIVANCEGLOBUS MEDICAL, INC.LPH2026-08-14
00193982895037TRIVANCEGLOBUS MEDICAL, INC.LPH2026-08-14
00193982895037TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895044TRIVANCEGLOBUS MEDICAL, INC.LPH2026-08-14
00193982895044TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895051TRIVANCEGLOBUS MEDICAL, INC.LPH2026-08-14
00193982895051TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895068TRIVANCEGLOBUS MEDICAL, INC.LPH2026-08-14
00193982895068TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14
00193982895075TRIVANCEGLOBUS MEDICAL, INC.JDI2026-08-14