EMPERION

Primary DI
03596010562050
Brand
EMPERION
Company
Smith & Nephew, Inc.
Model
71291704
Catalog number
71291704
Device description
EMPERION 13 SLEEVE MEDIUM CONE1 SPOUT TALL
Published
2015-08-29
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
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
K042127000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K042127000SMITH & NEPHEW MODULAR HIPSmith & Nephew, Inc.2004-11-19MEH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03596010562050PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03596010562050035960105620503596010562050

GMDN Terms#

Term, Definition table
TermDefinition
Coated hip femur prosthesis, modularA sterile implantable principal component of a total hip prosthesis (femoral component) 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 coated with a material (e.g., porous materials, hydroxyapatite) 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 may be performed with or without bone cement.

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
03596010194534SYNERGY71306709713067092015-08-30
03596010194541SYNERGY71306710713067102015-08-30
03596010194558SYNERGY71306711713067112015-08-30
03596010194565SYNERGY71306712713067122015-08-30
03596010194572SYNERGY71306713713067132015-08-30
03596010194589SYNERGY71306714713067142015-08-30
03596010194596SYNERGY71306715713067152015-08-30
03596010194602SYNERGY71306716713067162015-08-30
03596010194619SYNERGY71306717713067172015-08-30
03596010194626SYNERGY71306718713067182015-08-30
03596010384935SYNERGY71306409713064092015-08-29
03596010384942SYNERGY71306410713064102015-08-29
03596010384966SYNERGY71306411713064112015-08-29
03596010384973SYNERGY71306412713064122015-08-29
03596010384980SYNERGY71306413713064132015-08-30
03596010384997SYNERGY71306414713064142015-08-30
03596010385000SYNERGY71306415713064152015-08-30
03596010385017SYNERGY71306416713064162015-08-30
03596010385024SYNERGY71306417713064172015-08-30
03596010385031SYNERGY71306418713064182015-08-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07611996142389POLARSTEMSmith & Nephew, Inc.MEH2017-01-12
07611996142396POLARSTEMSmith & Nephew, Inc.MEH2016-09-01
07611996103410POLARSTEMSmith & Nephew, Inc.MEH2016-07-25
07611996103434POLARSTEMSmith & Nephew, Inc.MEH2016-07-25
07611996103489POLARSTEMSmith & Nephew, Inc.MEH2016-07-25
07611996103496POLARSTEMSmith & Nephew, Inc.MEH2016-07-25
07611996103502POLARSTEMSmith & Nephew, Inc.MEH2016-07-25
07611996103519POLARSTEMSmith & Nephew, Inc.MEH2016-07-25
07611996103533POLARSTEMSmith & Nephew, Inc.MEH2016-07-25
07611996103540POLARSTEMSmith & Nephew, Inc.MEH2016-07-25
07611996152692POLARSTEMSmith & Nephew, Inc.MEH2016-07-25
07611996103373POLARSTEMSmith & Nephew, Inc.MEH2016-07-22
07611996103380POLARSTEMSmith & Nephew, Inc.MEH2016-07-22
07611996103397POLARSTEMSmith & Nephew, Inc.MEH2016-07-22
07611996103403POLARSTEMSmith & Nephew, Inc.MEH2016-07-22
07613153071273RestorationHowmedica Osteonics Corp.MEH2015-09-24
07613153071280RestorationHowmedica Osteonics Corp.MEH2015-09-24
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07613153071310RestorationHowmedica Osteonics Corp.MEH2015-09-24
07613153071327RestorationHowmedica Osteonics Corp.MEH2015-09-24
07613153071334RestorationHowmedica Osteonics Corp.MEH2015-09-24
07613153071341RestorationHowmedica Osteonics Corp.MEH2015-09-24
07613153071358RestorationHowmedica Osteonics Corp.MEH2015-09-24
07613153071365RestorationHowmedica Osteonics Corp.MEH2015-09-24
07613153071372RestorationHowmedica Osteonics Corp.MEH2015-09-24
07613153071396RestorationHowmedica Osteonics Corp.MEH2015-09-24
07613153071402RestorationHowmedica Osteonics Corp.MEH2015-09-24