FDA.reportPublic FDA data

Omnifit

Primary DI
07613327101294
Brand
Omnifit
Company
Howmedica Osteonics Corp.
Model
2043C-2246
Catalog number
2043C-2246
Device description
0 Degree Series II Insert
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
LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
LWJProsthesis, hip, semi-constrained, metal/polymer, uncemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, CementedOrthopedic2
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedOrthopedic2
LWJProsthesis, Hip, Semi-Constrained, Metal/Polymer, UncementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K974685000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K974685000OSTEONICS POLYETHYLENE ACETABULAR COMPONENTSOsteonics Corp.1998-09-22JDI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327101294PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327101294076133271012947613327101294

GMDN Terms#

Term, Definition table
TermDefinition
Polyethylene acetabulum prosthesisA sterile implantable principal component of a total hip prosthesis (acetabular component) designed to replace or repair the acetabulum. The component is of a one-piece construction and is made entirely of polyethylene (polyethylene cup); it may include fixation devices (e.g., screws) for attachment to the body.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Lumen/Inner Diameter22Millimeter

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
04546540273260Orthinox6364-2-0266364-2-0262015-09-24
04546540273291Orthinox6364-2-0326364-2-0322015-09-24
04546540273314Orthinox6364-2-1266364-2-1262015-09-24
04546540273345Orthinox6364-2-1326364-2-1322015-09-24
04546540273369Orthinox6364-2-2266364-2-2262015-09-24
04546540273390Orthinox6364-2-2326364-2-2322015-09-24
04546540402158Orthinox6364-2-3226364-2-3222015-09-24
04546540402165Orthinox6364-2-3266364-2-3262015-09-24
04546540402172Orthinox6364-2-3286364-2-3282015-09-24
04546540402189Orthinox6364-2-3326364-2-3322015-09-24
04546540432001Trident502-11-46C502-11-46C2015-09-24
04546540568083Dall-Miles6704-3-0706704-3-0702015-09-24
04546540568090Dall-Miles6704-3-0806704-3-0802015-09-24
04546540568106Dall-Miles6704-3-0816704-3-0812015-09-24
04546540568113Dall-Miles6704-3-0826704-3-0822015-09-24
04546540568120Dall-Miles6704-3-0836704-3-0832015-09-24
04546540568137Dall-Miles6704-3-0906704-3-0902015-09-24
04546540568144Dall-Miles6704-3-0916704-3-0912015-09-24
04546540568151Dall-Miles6704-3-0926704-3-0922015-09-24
04546540568168Dall-Miles6704-3-0936704-3-0932015-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719886896466United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896473United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896480United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896497United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896503United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896510United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896527United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896534United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896541United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896558United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896565United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896572United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896589United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896596United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896633United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896640United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896657United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896664United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896671United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896688United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896695United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896701United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896718United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896725United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896732United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896749United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896756United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896763United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896770United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24
04719886896787United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-09-24