FDA.reportPublic FDA data

Biocore9 Femoral Resurfacing Component

Primary DI
00810068850451
Brand
Biocore9 Femoral Resurfacing Component
Company
Biocore9, LLC
Model
Femoral Resurfacing Component - 51 mm
Catalog number
01-03-0051
Device description
Biocore9 Femoral Resurfacing Head Component 51 mm
Published
2021-09-27
Public version status
New
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
K201219000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201219000Biocore9 Femoral Head Resurfacing ComponentBiocore9, LLC2021-01-19KXA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810068850451PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810068850451008100688504518100688504510810068850451

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter51Millimeter

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
093081548
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810068850079Biocore9 Acetabular Cup SystemAcetabular Cup Component - 50 mm - 0 HOLE01-01-00502026-06-26
00810068850086Biocore9 Acetabular Cup SystemAcetabular Cup Component - 52 mm - 0 HOLE01-01-00522026-06-26
00810068850093Biocore9 Acetabular Cup SystemAcetabular Cup Component - 54 mm - 0 HOLE01-01-00542026-06-26
00810068850109Biocore9 Acetabular Cup SystemAcetabular Cup Component - 56 mm - 0 HOLE01-01-00562026-06-26
00810068850116Biocore9 Acetabular Cup SystemAcetabular Cup Component - 58 mm - 0 HOLE01-01-00582026-06-26
00810068850123Biocore9 Acetabular Cup SystemAcetabular Cup Component - 60 mm - 0 HOLE01-01-00602026-06-26
00810068850130Biocore9 Acetabular Cup SystemAcetabular Cup Component - 62 mm - 0 HOLE01-01-00622026-06-26
00810068850147Biocore9 Acetabular Cup SystemAcetabular Cup Component - 64 mm - 0 HOLE01-01-00642026-06-26
00810068850154Biocore9 Acetabular Cup SystemAcetabular Cup Component - 66 mm - 0 HOLE01-01-00662026-06-26
00810068850185Biocore9 Acetabular Cup SystemAcetabular Cup Component - 52 mm - 5 HOLE01-01-05522026-06-26
00810068850192Biocore9 Acetabular Cup SystemAcetabular Cup Component - 54 mm - 5 HOLE01-01-05542026-06-26
00810068850208Biocore9 Acetabular Cup SystemAcetabular Cup Component - 58 mm - 5 HOLE01-01-05582026-06-26
00810068850215Biocore9 Acetabular Cup SystemAcetabular Cup Component - 60 mm - 5 HOLE01-01-05602026-06-26
00810068850222Biocore9 Acetabular Cup SystemAcetabular Cup Component - 62 mm - 5 HOLE01-01-05622026-06-26
00810068850239Biocore9 Acetabular Cup SystemAcetabular Cup Component - 64 mm - 5 HOLE01-01-05642026-06-26
00810068850246Biocore9 Acetabular Cup SystemAcetabular Cup Component - 66 mm - 5 HOLE01-01-05662026-06-26
00810068850284Biocore9 Acetabular Bearing SystemAcetabular Bearing Component - 41 mm I.D. x 52 mm 01-12-41522026-06-26
00810068850307Biocore9 Acetabular Bearing SystemAcetabular Bearing Component - 44 mm I.D. x 56 mm 01-12-44562026-06-26
00810068850321Biocore9 Acetabular Bearing SystemAcetabular Bearing Component - 47 mm I.D. x 60 mm 01-12-47602026-06-26
00810068850338Biocore9 Acetabular Bearing SystemAcetabular Bearing Component - 49 mm I.D. x 62 mm 01-12-49622026-06-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09348215185541Signature Resurfacing Femoral HeadSIGNATURE ORTHOPAEDICS PTY LTDKXA2026-07-29
09348215185558Signature Resurfacing Femoral HeadSIGNATURE ORTHOPAEDICS PTY LTDKXA2026-07-29
09348215185565Signature Resurfacing Femoral HeadSIGNATURE ORTHOPAEDICS PTY LTDKXA2026-07-29
09348215185572Signature Resurfacing Femoral HeadSIGNATURE ORTHOPAEDICS PTY LTDKXA2026-07-29
09348215185589Signature Resurfacing Femoral HeadSIGNATURE ORTHOPAEDICS PTY LTDKXA2026-07-29
09348215185596Signature Resurfacing Femoral HeadSIGNATURE ORTHOPAEDICS PTY LTDKXA2026-07-29
09348215185602Signature Resurfacing Femoral HeadSIGNATURE ORTHOPAEDICS PTY LTDKXA2026-07-29
09348215185619Signature Resurfacing Femoral HeadSIGNATURE ORTHOPAEDICS PTY LTDKXA2026-07-29
09348215185626Signature Resurfacing Femoral HeadSIGNATURE ORTHOPAEDICS PTY LTDKXA2026-07-29
09348215185633Signature Resurfacing Femoral HeadSIGNATURE ORTHOPAEDICS PTY LTDKXA2026-07-29
09348215185640Signature Resurfacing Femoral HeadSIGNATURE ORTHOPAEDICS PTY LTDKXA2026-07-29
09348215185657Signature Resurfacing Femoral HeadSIGNATURE ORTHOPAEDICS PTY LTDKXA2026-07-29
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
00814193025753SYNOVO 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