REFLECTION

Primary DI
03596010507075
Brand
REFLECTION
Company
Smith & Nephew, Inc.
Model
71335464
Catalog number
71335464
Device description
REFLECTION SCREWS PEGS REVISION HA PERIPHERAL HOLE SHELL 64MM G
Published
2015-08-30
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
LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K022556000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K022556000REFLECTION MODIFIED ACETABULAR SHELLSSmith & Nephew, Inc.2002-08-28LPH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03596010507075PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03596010507075035960105070753596010507075

GMDN Terms#

Term, Definition table
TermDefinition
Acetabular shellAn implantable component of a two-piece acetabulum prosthesis that forms the outer portion of the prosthesis, fixed to the pelvis to provide a base for the inner portion (acetabular liner). It is made of metal, and is fixed with bone cement and/or fixation devices.

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
07611996098075POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996098082POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996098099POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996098105POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996098112POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996098129POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996098136POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996098143POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996098150POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996098174POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996098501POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996098518POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996098525POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996098532POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996111323POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996111330POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996111354POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996111378POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996111392POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996111408POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996111415POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996111422POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996111446POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996111514POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996111538POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996111552POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996112320POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996112351POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996112368POLARCUPSmith & Nephew, Inc.LPH2015-11-25
07611996114638POLARCUPSmith & Nephew, Inc.LPH2015-11-25