FDA.reportPublic FDA data

DJO SURGICAL

Primary DI
00888912100656
Brand
DJO SURGICAL
Company
Encore Medical, L.P.
Model
933-36-264
Device description
LINER, ACETABULAR, 20 DH, HXL/FMP, 36MM ID 64MM CUP OD, MP11
Published
2017-08-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

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
00888912100656PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888912100656008889121006568889121006560888912100656

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
154074504
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190446776550DJO SURGICAL800-99-1632025-01-17
00190446776567DJO SURGICAL800-99-1642025-01-17
00190446906087DJO SURGICAL800-99-1672026-02-11
00190446706304DJO SURGICAL800-99-1482022-10-18
00190446706311DJO SURGICAL800-99-1492022-10-18
00190446706328DJO SURGICAL800-99-1512022-10-18
00190446706335DJO SURGICAL800-99-1522022-10-18
00190446757665DJO SURGICAL800-99-1592022-08-17
00190446757672DJO SURGICAL800-99-1602022-08-17
00190446764274DJO SURGICAL800-99-1612022-08-17
00888912024983DJO SURGICAL520-38-0142017-08-07
00888912024990DJO SURGICAL520-38-0182017-08-07
00888912025003DJO SURGICAL520-38-1182017-08-07
00888912025010DJO SURGICAL520-42-0202017-08-07
00888912025027DJO SURGICAL520-42-1162017-08-07
00888912025034DJO SURGICAL520-46-1162017-08-07
00888912025041DJO SURGICAL520-46-1202017-08-07
00888912025058DJO SURGICAL520-50-1182017-08-07
00888912025065DJO SURGICAL520-50-1222017-08-07
00888912025072DJO SURGICAL520-50-1262017-08-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840097513201Velora Acetabular System InstrumentationRestor3d, Inc.LPH2026-08-21
00840097536675Velora Acetabular System InstrumentationRestor3d, Inc.LPH2026-08-19
10885862013743NAExactech, Inc.LPH2022-09-20
10885862013750NAExactech, Inc.LPH2022-09-20
10885862022448NAExactech, Inc.LPH2022-09-19
10885862022455NAExactech, Inc.LPH2022-09-19
10885862029867NAExactech, Inc.LPH2022-09-19
10885862010551NAExactech, Inc.LPH2022-08-18
10885862010575NAExactech, Inc.LPH2022-08-18
10885862010582NAExactech, Inc.LPH2022-08-18
10885862010872NAExactech, Inc.LPH2022-08-18
10885862010889NAExactech, Inc.LPH2022-08-18
10885862010896NAExactech, Inc.LPH2022-08-18
10885862016690NAExactech, Inc.LPH2022-08-18
10885862016706NAExactech, Inc.LPH2022-08-18
10885862016713NAExactech, Inc.LPH2022-08-18
10885862016720NAExactech, Inc.LPH2022-08-18
10885862016737NAExactech, Inc.LPH2022-08-18
10885862016744NAExactech, Inc.LPH2022-08-18
10885862016751NAExactech, Inc.LPH2022-08-18
10885862016768AcuMatchExactech, Inc.LPH2022-08-18
10885862016775AcuMatchExactech, Inc.LPH2022-08-18
10885862016782AcuMatchExactech, Inc.LPH2022-08-18
10885862016799AcuMatchExactech, Inc.LPH2022-08-18
10885862016805AcuMatchExactech, Inc.LPH2022-08-18
10885862016812AcuMatchExactech, Inc.LPH2022-08-18
10885862016829AcuMatchExactech, Inc.LPH2022-08-18
10885862016836AcuMatchExactech, Inc.LPH2022-08-18
10885862016843AcuMatchExactech, Inc.LPH2022-08-18
10885862016973AcuMatchExactech, Inc.LPH2022-08-18