FDA.reportPublic FDA data

X-Change

Primary DI
04546540167729
Brand
X-Change
Company
Howmedica Osteonics Corp.
Model
0942-8-030
Catalog number
0942-8-030
Device description
FLAT MESH
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
JDJMesh, surgical, acetabular, hip, prosthesis
KWLProsthesis, hip, hemi-, femoral, metal
KWYProsthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
KWZProsthesis, hip, constrained, cemented or uncemented, metal/polymer
LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
LWJProsthesis, hip, semi-constrained, metal/polymer, uncemented
LZOProsthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
MAYProsthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish
MBLProsthesis, hip, semi-constrained, uncemented, metal/polymer, porous
MEHProsthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, CementedOrthopedic2
JDJMesh, Surgical, Acetabular, Hip, ProsthesisGeneral, Plastic Surgery2
KWLProsthesis, Hip, Hemi-, Femoral, MetalOrthopedic2
KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or UncementedOrthopedic2
KWZProsthesis, Hip, Constrained, Cemented Or Uncemented, Metal/PolymerOrthopedic2
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedOrthopedic2
LWJProsthesis, Hip, Semi-Constrained, Metal/Polymer, UncementedOrthopedic2
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedOrthopedic2
MAYProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic FinishOrthopedic2
MBLProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, PorousOrthopedic2
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium PhosphateOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04546540167729PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04546540167729045465401677294546540167729

GMDN Terms#

Term, Definition table
TermDefinition
Multi-purpose surgical mesh, metallicA sterile flat woven/knitted material made of a biocompatible metal (e.g., surgical stainless steel, tantalum) with appropriate mechanical characteristics for implantation. This non-dedicated device is used alone or in combination with synthetic materials (e.g., polymers) to support or protect tissues in reconstructive surgical procedures (e.g., to repair large chest wall defects or large abdominal incisional hernias) and/or orthopaedic procedures (e.g., cranioplasty, femoral reconstruction). Disposable devices associated with implantation (e.g., introducer needles, trocars) may be included.

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
07613327020786Secur-Fit6054-0509S6054-0509S2015-09-24
07613327020793Secur-Fit6054-0511S6054-0511S2015-09-24
07613327020809Secur-Fit6054-0610S6054-0610S2015-09-24
07613327020816Secur-Fit6054-0612S6054-0612S2015-09-24
07613327020823Secur-Fit6054-0812S6054-0812S2015-09-24
07613327020830Secur-Fit6054-0713S6054-0713S2015-09-24
07613327020847Secur-Fit6054-0711S6054-0711S2015-09-24
07613327020854Secur-Fit6054-0814S6054-0814S2015-09-24
07613327020861Secur-Fit6054-0913S6054-0913S2015-09-24
07613327020878Secur-Fit6054-1014S6054-1014S2015-09-24
07613327020885Secur-Fit6054-1016S6054-1016S2015-09-24
07613327020892Secur-Fit6054-0915S6054-0915S2015-09-24
07613327020908Secur-Fit6054-1115S6054-1115S2015-09-24
07613327020915Secur-Fit6054-1117S6054-1117S2015-09-24
07613327020922Secur-Fit6054-1216S6054-1216S2015-09-24
07613327020939Secur-Fit6054-1218S6054-1218S2015-09-24
07613327020946Secur-Fit6054-1317S6054-1317S2015-09-24
07613327020953Secur-Fit6054-1319S6054-1319S2015-09-24
07613327020960Secur-Fit6054-1418S6054-1418S2015-09-24
07613327020977Secur-Fit6054-1420S6054-1420S2015-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719886896602United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886896602United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886896602United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-10-15
04719886899030United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899030United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899030United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-10-15
04719886899047United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899047United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899047United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-10-15
04719886899054United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899054United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899054United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-10-15
04719886899061United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-10-15
04719886899061United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899061United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899078United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899078United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899078United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-10-15
04719886899085United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899085United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899085United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-10-15
04719886899092United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899092United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899092United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-10-15
04719886899108United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15
04719886899108United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899108United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-10-15
04719886899115United Hip SystemUNITED ORTHOPEDIC CORP.MEH2026-10-15
04719886899115United Hip SystemUNITED ORTHOPEDIC CORP.LPH2026-10-15
04719886899115United Hip SystemUNITED ORTHOPEDIC CORP.LZO2026-10-15