FDA.reportPublic FDA data

SYNOVO HIP COMPONENTS

Primary DI
00814193025753
Brand
SYNOVO HIP COMPONENTS
Company
Synovo Production
Model
01-03-0052
Catalog number
01-03-0052
Device description
HIP FEMORAL RESURFACING CUP -52.5 MM
Published
2024-03-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KXAProsthesis, Hip, Femoral, Resurfacing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KXAProsthesis, Hip, Femoral, ResurfacingOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K904870000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K904870000MODIFIED NEW JERSEY FEMORAL HIP RESURFACING COMPONEndotec, Inc.1991-05-23KXA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00814193025753PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814193025753008141930257538141930257530814193025753

GMDN Terms#

Term, Definition table
TermDefinition
Resurfacing metallic hip prosthesisAn implantable partial substitute for a disease-damaged hip joint intended to replace the articulating surfaces of the hip while preserving the natural femoral head and neck. It consists of a metallic femoral cap component, that is placed over (resurfaces) a surgically-prepared femoral head, and a metallic acetabular component; that is, both components are supplied together. Fixation devices for implantation (e.g., screws/bolts) may be included and implantation may be performed with or without bone cement. This device is commonly used for younger/active patients to avoid total hip replacements/revisions.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter52.5Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature5 Degrees Celsius40 Degrees Celsius
Storage Environment Temperature5 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
061486164
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00814193025975SYNOVO HIP COMPONENTS01-17-283901-17-28392024-03-14
00814193025982SYNOVO HIP COMPONENTS01-17-284001-17-28402024-03-14
00814193025999SYNOVO HIP COMPONENTS01-17-284201-17-28422024-03-14
00814193026002SYNOVO HIP COMPONENTS01-17-284101-17-28412024-03-14
00814193026019SYNOVO HIP COMPONENTS01-17-284301-17-28432024-03-14
00814193026026SYNOVO HIP COMPONENTS01-17-284401-17-28442024-03-14
00814193026033SYNOVO HIP COMPONENTS01-17-284501-17-28452024-03-14
00814193026040SYNOVO HIP COMPONENTS01-17-284601-17-28462024-03-14
00814193026057SYNOVO HIP COMPONENTS01-17-284701-17-28472024-03-14
00814193026064SYNOVO HIP COMPONENTS01-17-284801-17-28482024-03-14
00814193026071SYNOVO HIP COMPONENTS01-17-284901-17-28492024-03-14
00814193026088SYNOVO HIP COMPONENTS01-17-285001-17-28502024-03-14
00814193026095SYNOVO HIP COMPONENTS01-17-285201-17-28522024-03-14
00814193026101SYNOVO HIP COMPONENTS01-17-285101-17-28512024-03-14
00814193026118SYNOVO HIP COMPONENTS01-17-285301-17-28532024-03-14
00814193026125SYNOVO HIP COMPONENTS01-17-285401-17-28542024-03-14
00814193026132SYNOVO HIP COMPONENTS01-17-285501-17-28552024-03-14
00814193026149SYNOVO HIP COMPONENTS01-17-285601-17-28562024-03-14
00814193026156SYNOVO HIP COMPONENTS01-17-285701-17-28572024-03-14
00814193026163SYNOVO HIP COMPONENTS01-17-285801-17-28582024-03-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00814193025654SYNOVO HIP COMPONENTSSynovo ProductionKXA2024-03-02
00814193025661SYNOVO HIP COMPONENTSSynovo ProductionKXA2024-03-02
00814193025678SYNOVO HIP COMPONENTSSynovo ProductionKXA2024-03-02
00814193025685SYNOVO HIP COMPONENTSSynovo ProductionKXA2024-03-02
00814193025692SYNOVO HIP COMPONENTSSynovo ProductionKXA2024-03-02
00814193025708SYNOVO HIP COMPONENTSSynovo ProductionKXA2024-03-02
00814193025715SYNOVO HIP COMPONENTSSynovo ProductionKXA2024-03-02
00814193025722SYNOVO HIP COMPONENTSSynovo ProductionKXA2024-03-02
00814193025739SYNOVO HIP COMPONENTSSynovo ProductionKXA2024-03-01
00814193025746SYNOVO HIP COMPONENTSSynovo ProductionKXA2024-03-01
00810068850383Biocore9 Femoral Resurfacing ComponentBiocore9, LLCKXA2021-09-27
00810068850390Biocore9 Femoral Resurfacing ComponentBiocore9, LLCKXA2021-09-27
00810068850406Biocore9 Femoral Resurfacing ComponentBiocore9, LLCKXA2021-09-27
00810068850413Biocore9 Femoral Resurfacing ComponentBiocore9, LLCKXA2021-09-27
00810068850420Biocore9 Femoral Resurfacing ComponentBiocore9, LLCKXA2021-09-27
00810068850437Biocore9 Femoral Resurfacing ComponentBiocore9, LLCKXA2021-09-27
00810068850444Biocore9 Femoral Resurfacing ComponentBiocore9, LLCKXA2021-09-27
00810068850451Biocore9 Femoral Resurfacing ComponentBiocore9, LLCKXA2021-09-27
00810068850468Biocore9 Femoral Resurfacing ComponentBiocore9, LLCKXA2021-09-27
05055196901087Cormet 2000 Hemi-Hip Metallic Resurfacing ProsthesisCORIN LTDKXA2016-08-17
05055196901094Cormet 2000 Hemi-Hip Metallic Resurfacing ProsthesisCORIN LTDKXA2016-08-17
05055196901100Cormet 2000 Hemi-Hip Metallic Resurfacing ProsthesisCORIN LTDKXA2016-08-17
05055196901117Cormet 2000 Hemi-Hip Metallic Resurfacing ProsthesisCORIN LTDKXA2016-08-17
05055196901124Cormet 2000 Hemi-Hip Metallic Resurfacing ProsthesisCORIN LTDKXA2016-08-17
05055196901162Cormet 2000 Hemi-Hip Metallic Resurfacing ProsthesisCORIN LTDKXA2016-08-17
05055196901179Cormet 2000 Hemi-Hip Metallic Resurfacing ProsthesisCORIN LTDKXA2016-08-17
05055196901186Cormet 2000 Hemi-Hip Metallic Resurfacing ProsthesisCORIN LTDKXA2016-08-17
05055196901193Cormet 2000 Hemi-Hip Metallic Resurfacing ProsthesisCORIN LTDKXA2016-08-17
05055196901209Cormet 2000 Hemi-Hip Metallic Resurfacing ProsthesisCORIN LTDKXA2016-08-17
05055196901216Cormet 2000 Hemi-Hip Metallic Resurfacing ProsthesisCORIN LTDKXA2016-08-17