FDA.reportPublic FDA data

G7®

Primary DI
00887868466397
Brand
G7®
Company
Biomet Orthopedics, LLC
Model
110017253
Catalog number
110017253
Published
2022-06-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWZProsthesis, hip, constrained, cemented or uncemented, metal/polymer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWZProsthesis, Hip, Constrained, Cemented Or Uncemented, Metal/PolymerOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887868466397PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887868466397008878684663978878684663970887868466397

GMDN Terms#

Term, Definition table
TermDefinition
Acetabulum prosthesis trial, prefabricated, reusableA copy of a final acetabular prosthesis designed to be used for trial reductions during hip arthroplasty to judge the correct size and position of the final acetabular prosthesis to be implanted. It is one of a set, or a set, of graduated sizes, is typically made of metal or polymer material and may be designed in the form of cages, shells, augments, or inserts. This is a reusable device intended to be sterilized prior to use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889024706828Mini Baseplate Sizer Cannulated HandleSSI008562SSI0085622026-03-19
00889024706835Mini Baseplate Sizer 0 degree On-axis HandleSSI008561SSI0085612026-03-19
00887868551611StageOne Select4311904311902026-03-17
00887868551628StageOne Select4311914311912026-03-17
00887868551635StageOne Select4311924311922026-03-17
00887868551642StageOne Select4311934311932026-03-17
00887868551659StageOne Select4311944311942026-03-17
00887868551666StageOne Select4311954311952026-03-17
00887868551673StageOne Select4311964311962026-03-17
00887868551680StageOne Select4311974311972026-03-17
00887868551697StageOne Select4311984311982026-03-17
00887868551703STAGEONE SELECT4311994311992026-03-17
00889024706774Biomet®32-34169232-3416922026-03-12
00889024706781Biomet®32-14815332-1481532026-03-12
00889024706798Biomet®32-14815132-1481512026-03-12
00889024706804Biomet®32-34169732-3416972026-03-12
00889024706811Biomet®32-14814932-1481492026-03-12
00889024706484Vanguard®32-34702132-3470212026-02-27
00880304009615BMP CABLE CUTTER4980104980102020-05-23
00880304387676OPEN END CUTTER4980234980232020-05-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10885862661456N/AExactech, Inc.KWZ2026-03-19
10885862661463N/AExactech, Inc.KWZ2026-03-19
10885862661470N/AExactech, Inc.KWZ2026-03-19
10885862661487NovationExactech, Inc.KWZ2026-03-19
10885862661494NovationExactech, Inc.KWZ2026-03-19
10885862661500NovationExactech, Inc.KWZ2026-03-19
10885862661517NovationExactech, Inc.KWZ2026-03-19
10885862661524NovationExactech, Inc.KWZ2026-03-19
00889024683938G7® Revision Acetabular SystemZimmer, Inc.KWZ2026-02-10
00889024683945G7® Revision Acetabular SystemZimmer, Inc.KWZ2026-02-10
00889024686649G7® Revision Acetabular SystemZimmer, Inc.KWZ2026-02-10
00889024686656G7® Revision Acetabular SystemZimmer, Inc.KWZ2026-02-10
00889024686670G7® Revision Acetabular SystemZimmer, Inc.KWZ2026-02-10
00889024686694G7® Revision Acetabular SystemZimmer, Inc.KWZ2026-02-10
00889024686700G7® Revision Acetabular SystemZimmer, Inc.KWZ2026-02-10
00889024686731G7® Revision Acetabular SystemZimmer, Inc.KWZ2026-02-10
07630542722653Mpact Constrained LinerMedacta International SAKWZ2025-08-06
07630542722660Mpact Constrained LinerMedacta International SAKWZ2025-08-06
07630542722677Mpact Constrained LinerMedacta International SAKWZ2025-08-06
07630542722684Mpact Constrained LinerMedacta International SAKWZ2025-08-06
07630542722691Mpact Constrained LinerMedacta International SAKWZ2025-08-06
07630542722707Mpact Constrained LinerMedacta International SAKWZ2025-08-06
07630542722714Mpact Constrained LinerMedacta International SAKWZ2025-08-06
07630542722721Mpact Constrained LinerMedacta International SAKWZ2025-08-06
07630542722738Mpact Constrained LinerMedacta International SAKWZ2025-08-06
07630542722745Mpact Constrained LinerMedacta International SAKWZ2025-08-06
07630542722752Mpact Constrained LinerMedacta International SAKWZ2025-08-06
07630542722769Mpact Constrained LinerMedacta International SAKWZ2025-08-06
00889024670099Trabecular Metal® Acetabular Revision SystemZimmer, Inc.KWZ2024-11-05
00889024670105Trabecular Metal® Acetabular Revision SystemZimmer, Inc.KWZ2024-11-05