FDA.reportPublic FDA data

DJO SURGICAL

Primary DI
00888912099851
Brand
DJO SURGICAL
Company
DJO, LLC
Model
931-40-780
Device description
LINER/NON-HOODED-NEU, MP15, HXe-plus, 40mm
Published
2016-11-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
OQGHip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedOrthopedic2
OQGHip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, UncementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K130365000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130365000X-ALT HIGHLY CROSS LINKED VE ACETABULAR LINEREncore Medical L.P.2013-09-23OQG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888912099851PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888912099851008889120998518889120998510888912099851

GMDN Terms#

Term, Definition table
TermDefinition
Non-constrained polyethylene acetabular linerA sterile, implantable component of a two-piece acetabulum prosthesis that is inserted into an acetabular shell prosthesis to provide the articulating surface with a femoral head prosthesis as part of a total hip arthroplasty (THA). It is made of polyethylene (includes hylamer, cross-linked polyethylene), and does not include a stabilizing component to limit the range of motion of the hip.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
081840873
Device count
1
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190446979128AIRCAST31M-9002026-08-03
00190446898610CMFMFUSE012026-07-31
00190446660590PROCARE155-79-871132026-07-31
00190446660606PROCARE155-79-871142026-07-31
00190446660613PROCARE155-79-871172026-07-31
00190446660620PROCARE155-79-871182026-07-31
00190446660637PROCARE155-79-870502026-07-31
00190446660644PROCARE155-79-870602026-07-31
00190446922490CMFMANAGEL012026-07-31
00190446780601CHATTANOOGA81-50102023-04-25
00190446780618CHATTANOOGA81-50112023-04-25
00190446750598CHATTANOOGA47382022-09-02
00190446750604CHATTANOOGA47822022-09-02
00190446757214CHATTANOOGA4782-12022-09-02
00190446757221CHATTANOOGA4738-12022-09-02
00888912036627PROCARE79-892002022-08-22
00888912292856CHATTANOOGA2761-102016-09-15
00888912292863CHATTANOOGA2761-22016-09-15
00888912294249CHATTANOOGA2789-102016-09-15
00888912294256CHATTANOOGA2789-22016-09-15

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