FDA.reportPublic FDA data

NA

Primary DI
03596010619556
Brand
NA
Company
Smith & Nephew, Inc.
Model
71352116
Catalog number
71352116
Device description
LEFT ANTEVERTED MODULAR NECK
Published
2015-08-30
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
MEHProsthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium PhosphateOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K081124000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K081124000MDF REVISION HIP SYSTEMSmith & Nephew, Inc.2008-07-31MEH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03596010619556PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03596010619556035960106195563596010619556

GMDN Terms#

Term, Definition table
TermDefinition
Femoral stem prosthesis trialA copy of a final femoral stem prosthesis designed to be used for trial reductions during hip arthroplasty to judge the correct offset, leg-length, and range of motion of the final femoral prosthesis to be implanted. It is one of a set, or a set, of graduated sizes, and is used in conjunction with femoral head trial prostheses. It is typically made of metal or polymer material and includes trial stems, trial sleeves, and trial necks. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)821-5700gudid@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
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
00885556859759Titan Modular Shoulder SystemCSA-0920-21CSA-0920-212026-09-24
00885556859766Titan Modular Shoulder SystemCSA-0920-22CSA-0920-222026-09-24
00885556859773Titan Modular Shoulder SystemCSA-0920-23CSA-0920-232026-09-24
00885556859780Titan Modular Shoulder SystemCSA-0920-24CSA-0920-242026-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719886896466United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896473United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896480United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896497United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896503United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896510United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896527United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896534United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896541United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896558United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896565United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896572United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896589United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896596United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896633United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896640United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896657United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896664United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896671United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896688United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896695United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896701United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896718United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896725United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896732United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896749United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896756United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896763United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896770United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24
04719886896787United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-09-24