DJO SURGICAL

Primary DI
00888912087032
Brand
DJO SURGICAL
Company
DJO, LLC
Model
494-00-066
Device description
ACE CAGE, STD. 66mm
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
00888912087032PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888912087032008889120870328889120870320888912087032

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
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
00888912296977CHATTANOOGA28742016-09-15
00888912297110CHATTANOOGA28762016-09-15
00888912297295CHATTANOOGA28782016-09-15
00888912335652CHATTANOOGA39-07012016-09-15
00888912335669CHATTANOOGA39-07022016-09-15
00888912267588CHATTANOOGA20252026-03-31
00888912267618CHATTANOOGA20272026-03-31
00888912267625CHATTANOOGA20282026-03-31
00888912267632CHATTANOOGA20292026-03-31

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Primary DI, Brand, Company table
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07611996074949SL-PLUSSmith & Nephew, Inc.LWJ2016-08-19
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07611996074987SL-PLUSSmith & Nephew, Inc.LWJ2016-08-19
07611996074994SL-PLUSSmith & Nephew, Inc.LWJ2016-08-19
07611996075007SL-PLUSSmith & Nephew, Inc.LWJ2016-08-19
07611996075014SL-PLUSSmith & Nephew, Inc.LWJ2016-08-19
07611996075038SL-PLUSSmith & Nephew, Inc.LWJ2016-08-19
07611996095586SLR-PLUSSmith & Nephew, Inc.LWJ2016-08-19
07611996095593SLR-PLUSSmith & Nephew, Inc.LWJ2016-08-19
07611996095609SLR-PLUSSmith & Nephew, Inc.LWJ2016-08-19
07611996095623SLR-PLUSSmith & Nephew, Inc.LWJ2016-08-19
07611996095630SLR-PLUSSmith & Nephew, Inc.LWJ2016-08-19
07611996095647SLR-PLUSSmith & Nephew, Inc.LWJ2016-08-19
07611996095654SLR-PLUSSmith & Nephew, Inc.LWJ2016-08-19
07611996095661SLR-PLUSSmith & Nephew, Inc.LWJ2016-08-19
07611996095678SLR-PLUSSmith & Nephew, Inc.LWJ2016-08-19
07611996103427POLARSTEMSmith & Nephew, Inc.LWJ2016-07-25
07611996103434POLARSTEMSmith & Nephew, Inc.LWJ2016-07-25
07611996103441POLARSTEMSmith & Nephew, Inc.LWJ2016-07-25
07611996103458POLARSTEMSmith & Nephew, Inc.LWJ2016-07-25