FDA.reportPublic FDA data

Reflection

Primary DI
03596010487889
Brand
Reflection
Company
Smith & Nephew, Inc.
Model
71929750
Catalog number
71929750
Device description
REFLECTION TRL SHELL 46MM
Published
2015-11-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JDIProsthesis, hip, semi-constrained, metal/polymer, cemented

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123598000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123598000SMITH & NEPHEW, INC. HIP SYSTEM INSTRUMENTATIONSmith & Nephew, Inc.2013-06-28JDI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03596010487889PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03596010487889035960104878893596010487889

GMDN Terms#

Term, Definition table
TermDefinition
Acetabulum prosthesis trial, prefabricated, reusableA copy of a final acetabular prosthesis designed to be used for trial reductions during hip arthroplasty to judge the correct size and position of the final acetabular prosthesis to be implanted. It is one of a set, or a set, of graduated sizes, is typically made of metal or polymer material and may be designed in the form of cages, shells, augments, or inserts. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)238-7538GUDID@SMITH-NEPHEW.COM

Regulatory Flags#

DUNS number
045483575
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00885556165560NA76515310765153102026-07-16
00885556923023NA76547001765470012026-07-16
00885556925089NA74034445740344452026-07-14
00885556925379CORIOGRAPHROB20032ROB200322026-07-08
00885556925386CORIOGRAPHROB20031ROB200312026-07-08
00885556904879EVOS70887105708871052026-06-25
00885556904923EVOS70897130708971302026-06-25
00885556906163EVOS70879090708790902026-06-25
00885556906170EVOS70879095708790952026-06-25
00885556906187EVOS70879100708791002026-06-25
00885556906194EVOS70879105708791052026-06-25
00885556906200EVOS70879110708791102026-06-25
00885556906217EVOS70879115708791152026-06-25
00885556906224EVOS70879120708791202026-06-25
00885556906231EVOS70879125708791252026-06-25
00885556906248EVOS70879130708791302026-06-25
00885556906255EVOS70879135708791352026-06-25
00885556906262EVOS70879140708791402026-06-25
00885556906279EVOS70879145708791452026-06-25
00885556906286EVOS70879150708791502026-06-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810068850079Biocore9 Acetabular Cup SystemBiocore9, LLCJDI2026-06-26
00810068850086Biocore9 Acetabular Cup SystemBiocore9, LLCJDI2026-06-26
00810068850093Biocore9 Acetabular Cup SystemBiocore9, LLCJDI2026-06-26
00810068850109Biocore9 Acetabular Cup SystemBiocore9, LLCJDI2026-06-26
00810068850123Biocore9 Acetabular Cup SystemBiocore9, LLCJDI2026-06-26
00810068850130Biocore9 Acetabular Cup SystemBiocore9, LLCJDI2026-06-26
00810068850147Biocore9 Acetabular Cup SystemBiocore9, LLCJDI2026-06-26
00810068850154Biocore9 Acetabular Cup SystemBiocore9, LLCJDI2026-06-26
00810068850185Biocore9 Acetabular Cup SystemBiocore9, LLCJDI2026-06-26
00810068850192Biocore9 Acetabular Cup SystemBiocore9, LLCJDI2026-06-26
00810068850208Biocore9 Acetabular Cup SystemBiocore9, LLCJDI2026-06-26
00810068850215Biocore9 Acetabular Cup SystemBiocore9, LLCJDI2026-06-26
00810068850222Biocore9 Acetabular Cup SystemBiocore9, LLCJDI2026-06-26
00810068850239Biocore9 Acetabular Cup SystemBiocore9, LLCJDI2026-06-26
00810068850246Biocore9 Acetabular Cup SystemBiocore9, LLCJDI2026-06-26
00810068850284Biocore9 Acetabular Bearing SystemBiocore9, LLCJDI2026-06-26
00810068850307Biocore9 Acetabular Bearing SystemBiocore9, LLCJDI2026-06-26
00810068850321Biocore9 Acetabular Bearing SystemBiocore9, LLCJDI2026-06-26
00810068850338Biocore9 Acetabular Bearing SystemBiocore9, LLCJDI2026-06-26
00810068850345Biocore9 Acetabular Bearing SystemBiocore9, LLCJDI2026-06-26
00810068850635Biocore9 Acetabular Cup SystemBiocore9, LLCJDI2026-06-26
00810068850642Biocore9 Acetabular Cup SystemBiocore9, LLCJDI2026-06-26
00810068850703Biocore9 Acetabular Bearing SystemBiocore9, LLCJDI2026-06-26
00810068850710Biocore9 Acetabular Bearing SystemBiocore9, LLCJDI2026-06-26
00810068850727Biocore9 Acetabular Bearing SystemBiocore9, LLCJDI2026-06-26
00810068850734Biocore9 Acetabular Bearing SystemBiocore9, LLCJDI2026-06-26
00810068850741Biocore9 Acetabular Bearing SystemBiocore9, LLCJDI2026-06-26
00810068850758Biocore9 Acetabular Bearing SystemBiocore9, LLCJDI2026-06-26
00810068850772Biocore9 Acetabular Bearing SystemBiocore9, LLCJDI2026-06-26
00810068850895Biocore9 Acetabular Bearing SystemBiocore9, LLCJDI2026-06-26