FDA.reportPublic FDA data

ESOP®

Primary DI
03661489450389
Brand
ESOP®
Company
FOURNITURES HOSPITALIERES INDUSTRIE
Model
245038 - ACETABULAR LINER/PE, Ø22,22 / Ø48
Published
2015-10-24
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
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium PhosphateOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K961388000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K961388000ATLAS III ACETABULAR CUPFournitures Hospitalieres1997-04-03MEH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03661489450389PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03661489450389036614894503893661489450389

GMDN Terms#

Term, Definition table
TermDefinition
Acetabular shellAn 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
261839898
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03661489724442JARVIS GUIDE DE COUPE EXTRA-MODULAIRE272444-JARVIS GUIDE DE COUPE EXTRA-MODULAIRE2026-05-08
03661489724459JARVIS COMPACTEUR INITIAL AMOVIBLE272445-JARVIS COMPACTEUR INITIAL AMOVIBLE2026-05-08
03661489724466JARVIS HUMERAL TRAY N°1272446-JARVIS HUMERAL TRAY N°12026-05-08
03661489724473JARVIS HUMERAL TRAY N°2272447-JARVIS HUMERAL TRAY N°22026-05-08
03661489724480JARVIS HUMERAL INSERT BOX272448-JARVIS HUMERAL INSERT BOX2026-05-08
03661489708275ARROW Reverse Porous Glenoid270827 - ARROW SCREWDRIVER D3.52026-02-18
03661489718175ARROW Short Stem Humeral System271817 - ARROW BROCHE D3 L3502026-02-18
03661489723629JARVIS METAPHYSEAL STEM272362 - JARVIS METAPHYSEAL STEM V2 T12026-01-15
03661489723636JARVIS METAPHYSEAL STEM272363 - JARVIS METAPHYSEAL STEM V2 T22026-01-15
03661489723643JARVIS METAPHYSEAL STEM272364 - JARVIS METAPHYSEAL STEM V2 T32026-01-15
03661489723650JARVIS METAPHYSEAL STEM272365 - JARVIS METAPHYSEAL STEM V2 T42026-01-15
03661489723667JARVIS METAPHYSEAL STEM272366 - JARVIS METAPHYSEAL STEM V2 T52026-01-15
03661489723674JARVIS METAPHYSEAL STEM272367 - JARVIS METAPHYSEAL STEM V2 T62026-01-15
03661489724213JARVIS METAPHYSEAL STEM272421 - JARVIS MODULAR BROACH T12026-01-15
03661489724220JARVIS METAPHYSEAL STEM272422 - JARVIS MODULAR BROACH T22026-01-15
03661489724237JARVIS METAPHYSEAL STEM272423 - JARVIS MODULAR BROACH T32026-01-15
03661489724244JARVIS METAPHYSEAL STEM272424 - JARVIS MODULAR BROACH T42026-01-15
03661489724251JARVIS METAPHYSEAL STEM272425 - JARVIS MODULAR BROACH T52026-01-15
03661489724268JARVIS METAPHYSEAL STEM272426 - JARVIS MODULAR BROACH T62026-01-15
03661489523618JARVIS Diaphyseal Stem Standard272361 - JARVIS DIAPHYSEAL TRIAL STEM STANDARD D162025-12-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04026575448678MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGMEH2026-07-09
04026575448685MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGMEH2026-07-09
04026575448760MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGMEH2026-07-09
04026575448777MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGMEH2026-07-09
04026575448784MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGMEH2026-07-09
04026575448791MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGMEH2026-07-09
04026575448807MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGMEH2026-07-09
04026575448814MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGMEH2026-07-09
04026575448821MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGMEH2026-07-09
04026575448838MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGMEH2026-07-09
04026575448845MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGMEH2026-07-09
04026575448852MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGMEH2026-07-09
04026575448869MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGMEH2026-07-09
04026575448876MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGMEH2026-07-09
04026575448883MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGMEH2026-07-09
04026575448890MobileLink Acetabular Cup SystemWALDEMAR LINK GmbH & Co. KGMEH2026-07-09
00843575126801Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575126818Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575126825Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575126832Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575126849Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575126856Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575126863Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575126870Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575126887Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575126894Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575126900Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575126917Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575126924Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29
00843575126931Primo™ Acetabular SystemB-ONE ORTHO, CORP.MEH2026-05-29