FDA.reportPublic FDA data

SYNERGY

Primary DI
03596010194466
Brand
SYNERGY
Company
Smith & Nephew, Inc.
Model
71306612
Catalog number
71306612
Device description
SYNERGY POROUS COATED FEMORAL SIZE 12
Published
2015-05-06
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
MRAProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MRAProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or UncementedUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P030022000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P030022000REFLECTION CERAMIC ACETABULAR SYSTEMSmith & Nephew, Inc.2004-12-17MRA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03596010194466PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03596010194466035960101944663596010194466

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-238-7538GUDID@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
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
M684PLS0R4111ProfemurMicroport Orthopedics Inc.MRA2016-09-24
M684PLS0R4121ProfemurMicroport Orthopedics Inc.MRA2016-09-24
M684PLS0R4131ProfemurMicroport Orthopedics Inc.MRA2016-09-24
M684PLS0R4141ProfemurMicroport Orthopedics Inc.MRA2016-09-24
M684PLS0R4161ProfemurMicroport Orthopedics Inc.MRA2016-09-24
M684PLS0S4101ProfemurMicroport Orthopedics Inc.MRA2016-09-24
M684PLS0R4101ProfemurMicroport Orthopedics Inc.MRA2016-09-24
M684PLS0R4151ProfemurMicroport Orthopedics Inc.MRA2016-09-24
M684260000041LineageMicroport Orthopedics Inc.MRA2016-08-31
M684260000051LineageMicroport Orthopedics Inc.MRA2016-08-31
M684260000061LineageMicroport Orthopedics Inc.MRA2016-08-31
M684260000071LineageMicroport Orthopedics Inc.MRA2016-08-31
M684260000081LineageMicroport Orthopedics Inc.MRA2016-08-31
M684260000091LineageMicroport Orthopedics Inc.MRA2016-08-31
M684260000101LineageMicroport Orthopedics Inc.MRA2016-08-31
M684260000111LineageMicroport Orthopedics Inc.MRA2016-08-31
M684260000121LineageMicroport Orthopedics Inc.MRA2016-08-31
M684260000131LineageMicroport Orthopedics Inc.MRA2016-08-31
M684260000141LineageMicroport Orthopedics Inc.MRA2016-08-31
M684260000151LineageMicroport Orthopedics Inc.MRA2016-08-31
M684365800461LineageMicroport Orthopedics Inc.MRA2016-08-31
M684365800481LineageMicroport Orthopedics Inc.MRA2016-08-31
M684365800501LineageMicroport Orthopedics Inc.MRA2016-08-31
M684365800521LineageMicroport Orthopedics Inc.MRA2016-08-31
M684365800541LineageMicroport Orthopedics Inc.MRA2016-08-31
M684365800561LineageMicroport Orthopedics Inc.MRA2016-08-31
M684365800581LineageMicroport Orthopedics Inc.MRA2016-08-31
M684365800601LineageMicroport Orthopedics Inc.MRA2016-08-31
M684365800621LineageMicroport Orthopedics Inc.MRA2016-08-31
M684365800641LineageMicroport Orthopedics Inc.MRA2016-08-31