FDA.reportPublic FDA data

Omnifit

Primary DI
07613327021684
Brand
Omnifit
Company
Howmedica Osteonics Corp.
Model
6033-0425
Catalog number
6033-0425
Device description
Normalized Hip Stem
Published
2015-09-24
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
JDIProsthesis, hip, semi-constrained, metal/polymer, cemented
LZOProsthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, CementedOrthopedic2
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K913812000
K932519000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K913812000OMNIFIT/OMNIFLEX/ODC/OMNIFIT-HA HIP STEM SERIESOsteonics Corp.1991-11-22JDI
K932519000OSTEONICS(R) OMNIFIT(R) NORMALIZED HIP STEMOsteonics Corp.1994-03-10LZO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327021684PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327021684076133270216847613327021684

GMDN Terms#

Term, Definition table
TermDefinition
Uncoated hip femur prosthesis, modularA sterile implantable principal component of a total hip prosthesis (femoral component) typically 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 not coated with materials 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 is intended to be performed with bone cement.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
058311945
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04546540035523Omnifit2041C-22402041C-22402015-09-24
04546540035714Omnifit2041C-28462041C-28462015-09-24
04546540035790Omnifit2041C-32502041C-32502015-09-24
04546540035806Omnifit2041C-32542041C-32542015-09-24
04546540035813Omnifit2041C-32582041C-32582015-09-24
04546540035820Omnifit2041C-32622041C-32622015-09-24
04546540035837Omnifit2041C-32662041C-32662015-09-24
07613327016772UHRUH1-36-22UH1-36-222015-09-24
07613327016789UHRUH1-38-22UH1-38-222015-09-24
07613327016796UHRUH1-40-22UH1-40-222015-09-24
07613327016802UHRUH1-41-26UH1-41-262015-09-24
07613327016819UHRUH1-41-22UH1-41-222015-09-24
07613327016826UHRUH1-42-26UH1-42-262015-09-24
07613327016833UHRUH1-42-22UH1-42-222015-09-24
07613327016840UHRUH1-43-22UH1-43-222015-09-24
07613327016857UHRUH1-42-28UH1-42-282015-09-24
07613327016864UHRUH1-43-26UH1-43-262015-09-24
07613327016871UHRUH1-44-22UH1-44-222015-09-24
07613327016888UHRUH1-44-26UH1-44-262015-09-24
07613327016895UHRUH1-44-28UH1-44-282015-09-24

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