FDA.reportPublic FDA data

DJO SURGICAL

Primary DI
00888912087070
Brand
DJO SURGICAL
Company
DJO, LLC
Model
494-01-054
Device description
ACE CAGE, LONG 54mm
Published
2016-10-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LWJProsthesis, hip, semi-constrained, metal/polymer, uncemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LWJProsthesis, Hip, Semi-Constrained, Metal/Polymer, UncementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K002941000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K002941000ACETABULAR PLATESEncore Orthopedics, Inc.2000-12-04LWJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888912087070PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888912087070008889120870708889120870700888912087070

GMDN Terms#

Term, Definition table
TermDefinition
Acetabular shellA sterile, implantable component of a two-piece acetabulum prosthesis that forms the outer portion of the prosthesis, fixed to the pelvis to provide a base for the inner portion (acetabular liner). It is made of metal, and is fixed with bone cement and/or fixation devices.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
081840873
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
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
00193982895006TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895013TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895020TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895037TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895044TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895051TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895068TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895075TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895082TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895099TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895105TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895112TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895136TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895143TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895150TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895167TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895174TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895181TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895198TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895204TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895211TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895228TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895235TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895242TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895266TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895273TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895280TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895297TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895303TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14
00193982895310TRIVANCEGLOBUS MEDICAL, INC.LWJ2026-08-14