FDA.reportPublic FDA data

REFLECTION

Primary DI
03596010197634
Brand
REFLECTION
Company
Smith & Nephew, Inc.
Model
71336500
Catalog number
71336500
Device description
REF THREADED HOLE COVER
Published
2015-08-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MBLProsthesis, hip, semi-constrained, uncemented, metal/polymer, porous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MBLProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, PorousOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K070756000
K211176000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070756000SMITH AND NEPHEW REFLECTION 3 ACETABULAR SYSTEMSmith & Nephew, Inc.2007-06-06MBL
K211176000Smith & Nephew Hip SystemsSmith & Nephew, Inc.2022-07-01LPH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03596010197634PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03596010197634035960101976343596010197634

GMDN Terms#

Term, Definition table
TermDefinition
Acetabulum prosthesis hole plugA sterile implantable device designed as a threaded or non-threaded plug intended to fill any hole of the shell component of a two-piece acetabulum prosthesis (shell and liner). It is made of metallic or polymer material, and is screwed or pushed into the hole after the implantation of the shell component.

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
00885554009101NA720770572077052015-08-30
00885556925690NAROB30080ROB300802026-06-04
03596010589101JOURNEY71422274714222742015-08-30
03596010589132JOURNEY71422277714222772015-08-30
03596010000675OXINIUM71343603713436032015-08-30
03596010474148OXINIUM71342800713428002015-08-30
03596010474162OXINIUM71342804713428042015-08-30
03596010474179OXINIUM71342808713428082015-08-30
03596010474209OXINIUM71343200713432002015-08-30
03596010474216OXINIUM71343203713432032015-08-30
03596010474223OXINIUM71343204713432042015-08-30
03596010474230OXINIUM71343208713432082015-08-30
03596010477279OXINIUM71343600713436002015-08-30
03596010477286OXINIUM71343604713436042015-08-30
03596010477293OXINIUM71343608713436082015-08-30
03596010488862OXINIUM71342200713422002015-08-30
03596010544193JOURNEY71461012714610122015-08-30
03596010544209JOURNEY71461013714610132015-08-30
03596010544216JOURNEY71461014714610142015-08-30
03596010544223JOURNEY71461015714610152015-08-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07613153071327RestorationHowmedica Osteonics Corp.MBL2015-09-24
07613153071334RestorationHowmedica Osteonics Corp.MBL2015-09-24
07613153071341RestorationHowmedica Osteonics Corp.MBL2015-09-24
07613153071358RestorationHowmedica Osteonics Corp.MBL2015-09-24
07613153071365RestorationHowmedica Osteonics Corp.MBL2015-09-24
07613153071372RestorationHowmedica Osteonics Corp.MBL2015-09-24
07613153071389RestorationHowmedica Osteonics Corp.MBL2015-09-24
07613153071396RestorationHowmedica Osteonics Corp.MBL2015-09-24
07613153071402RestorationHowmedica Osteonics Corp.MBL2015-09-24
07613153071419RestorationHowmedica Osteonics Corp.MBL2015-09-24
07613153071426RestorationHowmedica Osteonics Corp.MBL2015-09-24
07613153071433RestorationHowmedica Osteonics Corp.MBL2015-09-24
07613153071440RestorationHowmedica Osteonics Corp.MBL2015-09-24
07613153071518RestorationHowmedica Osteonics Corp.MBL2015-09-24
07613153071587RestorationHowmedica Osteonics Corp.MBL2015-09-24
07613153071594RestorationHowmedica Osteonics Corp.MBL2015-09-24
07613153071600RestorationHowmedica Osteonics Corp.MBL2015-09-24
07613153071617RestorationHowmedica Osteonics Corp.MBL2015-09-24
07613153071631RestorationHowmedica Osteonics Corp.MBL2015-09-24
07613153071648RestorationHowmedica Osteonics Corp.MBL2015-09-24
07613153071655RestorationHowmedica Osteonics Corp.MBL2015-09-24
07613153072867TridentHowmedica Osteonics Corp.MBL2015-09-24
07613153072874TridentHowmedica Osteonics Corp.MBL2015-09-24
07613153072881TridentHowmedica Osteonics Corp.MBL2015-09-24
07613153072898TridentHowmedica Osteonics Corp.MBL2015-09-24
07613153072904TridentHowmedica Osteonics Corp.MBL2015-09-24