FDA.reportPublic FDA data

G7 DUAL MOBILITY

Primary DI
00880304734951
Brand
G7 DUAL MOBILITY
Company
Biomet Orthopedics, LLC
Model
110026614
Catalog number
110026614
Published
2020-04-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWYProsthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
LZOProsthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
OQGHip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or UncementedOrthopedic2
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedOrthopedic2
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedOrthopedic2
OQGHip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, UncementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150522000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150522000G7 Dual Mobility SystemBiomet, Inc.2015-05-01LPH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00880304734951PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00880304734951008803047349518803047349510880304734951

GMDN Terms#

Term, Definition table
TermDefinition
Femoral head prosthesis trialA copy of a final femoral head prosthesis designed to be used for trial reductions during hip arthroplasty to judge the correct size, and to help achieve the desired offset, leg-length, and range of motion of the final prosthesis to be implanted. It is one of a set, or a set, of graduated sizes, and is used in conjunction with femoral stem trial or final prostheses; some may be used with explantation instruments during removal of implanted acetabulum cups. It is typically made of metal or polymer material and includes trial adapters used with large trial heads. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)348-9500customerservice@zimmerbiomet.com

Regulatory Flags#

DUNS number
129278169
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00880304474185Arcos® Modular Revision Hip System11-30210211-3021022015-10-24
00880304474246Arcos® Modular Revision Hip System11-30210111-3021012015-10-24
00880304539259Arcos® Modular Revision Hip System11-30210911-3021092015-10-24
00889024711280Jgrknt Reusable Fishmouth Perc GuideSSI008662SSI0086622026-08-25
00889024712034Percutaneous Soft Anchor Short 1.4mm GuideSSI008661SSI0086612026-08-25
00880304527386Active Articulation0100009900100009902020-05-15
00880304527393Active Articulation0100009910100009912020-05-15
00880304485020Active Articulation Hip SystemEP-200144EP-2001442015-11-03
00880304485037Active Articulation Hip SystemEP-200146EP-2001462015-11-03
00880304485044Active Articulation Hip SystemEP-200148EP-2001482015-10-24
00880304485051Active Articulation Hip SystemEP-200150EP-2001502015-10-24
00880304485068Active Articulation Hip SystemEP-200152EP-2001522015-10-24
00880304485075Active Articulation Hip SystemEP-200154EP-2001542015-10-24
00880304485082Active Articulation Hip SystemEP-200156EP-2001562015-10-24
00880304485099Active Articulation Hip SystemEP-200158EP-2001582015-10-24
00880304485105Active Articulation Hip SystemEP-200160EP-2001602015-10-24
00880304485112Active Articulation Hip SystemEP-200162EP-2001622015-10-24
00880304485129Active Articulation Hip SystemEP-200164EP-2001642015-11-04
00880304485136Active Articulation Hip SystemEP-200166EP-2001662015-10-24
00880304491328Active Articulation™ Dual Mobility Hip SystemXL-200144XL-2001442015-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630030883576Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883583Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883590Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883606Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883613Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883620Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883637Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883644Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883651Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883668Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883675Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883682Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883699Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883705Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883712Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883729Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883736Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883743Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883750Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883767Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883774Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883781Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883798Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883804Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883811Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883828Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883835Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883842Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883859Mpact 3D Metal FoamMedacta International SALPH2026-09-04
07630030883866Mpact 3D Metal FoamMedacta International SALPH2026-09-04