FDA.reportPublic FDA data

DJO SURGICAL

Primary DI
00190446308263
Brand
DJO SURGICAL
Company
Encore Medical, L.P.
Model
400-00-282
Device description
Head, Femoral, CoCr, 28mm, 0mm
Published
2020-09-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true

Product Codes#

Code, Name table
CodeName
LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K072154000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K072154000FOUNDATION (FMP) POROUS COATED SPIKED ACETABULAR SYSTEMEncore Medical L.P.2007-12-14LPH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190446308263PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190446308263001904463082631904463082630190446308263

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
00713864000047DJO SURGICALS-2019962026-11-04
00190446851417DJO SURGICAL800-99-1652024-06-25
00190446735144DJO SURGICAL800-05-0802022-08-17
00190446735151DJO SURGICAL800-05-1322022-08-17
00190446735168DJO SURGICAL800-05-1332022-08-17
00190446735175DJO SURGICAL800-05-1342022-08-17
00190446735182DJO SURGICAL800-05-1352022-08-17
00190446735199DJO SURGICAL800-05-1362022-08-17
00190446735205DJO SURGICAL800-05-1372022-08-17
00190446735212DJO SURGICAL800-05-1382022-08-17
00190446735229DJO SURGICAL800-05-1392022-08-17
00190446735236DJO SURGICAL800-05-1402022-08-17
00190446735243DJO SURGICAL800-05-1412022-08-17
00190446735304DJO SURGICAL800-05-1462022-08-17
00190446735311DJO SURGICAL800-05-1472022-08-17
00190446735328DJO SURGICAL800-05-1482022-08-17
00190446735335DJO SURGICAL800-05-1492022-08-17
00190446735342DJO SURGICAL800-05-1502022-08-17
00190446735359DJO SURGICAL800-05-1512022-08-17
00190446735366DJO SURGICAL800-05-1522022-08-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00889024713512G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713529G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713536G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713543G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713550G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713567G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713574G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713581G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713598G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713604G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713611G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713628G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713635G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713642G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713659G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713666G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713673G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713680G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713697G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713703G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713734G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713741G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713758G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713765G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713772G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713789G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713796G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713802G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713819G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03
00889024713826G7® TM Acetabular SystemZimmer, Inc.LPH2026-11-03