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

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00885556837825Total Foot System 23820003820002022-12-22
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00885556841525XT Revision Ankle Replacement SystemMJU944TMJU944T2022-12-21
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00885556858325PyroCarbon PIP Total Joint SystemOSG-200-10PVOSG-200-10PV2022-12-22
00885556858349PyroCarbon PIP Total Joint SystemOSG-200-20PVOSG-200-20PV2022-12-22
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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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07630542796586Mfinity Femoral SystemMedacta International SAMEH2026-08-25
07630542796593Mfinity Femoral SystemMedacta International SAMEH2026-08-25
07630542796609Mfinity Femoral SystemMedacta International SAMEH2026-08-25
07630542796616Mfinity Femoral SystemMedacta International SAMEH2026-08-25
07630542796623Mfinity Femoral SystemMedacta International SAMEH2026-08-25
07630542796630Mfinity Femoral SystemMedacta International SAMEH2026-08-25
07630542796647Mfinity Femoral SystemMedacta International SAMEH2026-08-25
07630542796654Mfinity Femoral SystemMedacta International SAMEH2026-08-25
07630542796661Mfinity Femoral SystemMedacta International SAMEH2026-08-25
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