FDA.reportPublic FDA data

INSTRUMENT

Primary DI
07613327363500
Brand
INSTRUMENT
Company
Howmedica Osteonics Corp.
Model
7002-0166
Catalog number
7002-0166
Device description
TRIDENT II WINDOW TRIAL
Published
2017-11-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
07613327363500PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327363500076133273635007613327363500

GMDN Terms#

Term, Definition table
TermDefinition
Acetabulum prosthesis trial, 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

Regulatory Flags#

DUNS number
058311945
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
07613327660180Instrument5533-T-409-R5533-T-409-R2026-02-27
07613327648386Instrument5533-T-812-R5533-T-812-R2026-02-26
07613327648393Instrument5533-T-811-L5533-T-811-L2026-02-26
07613327648409Instrument5533-T-812-L5533-T-812-L2026-02-26
07613327648416Instrument5533-T-810-R5533-T-810-R2026-02-26
07613327648423Instrument5533-T-816-L5533-T-816-L2026-02-26
07613327648430Instrument5533-T-809-L5533-T-809-L2026-02-26
07613327648447Instrument5533-T-814-R5533-T-814-R2026-02-26
07613327648454Instrument5533-T-809-R5533-T-809-R2026-02-26
07613327648461Instrument5533-T-810-L5533-T-810-L2026-02-26
07613327648478Instrument5533-T-811-R5533-T-811-R2026-02-26
07613327648485Instrument5533-T-816-R5533-T-816-R2026-02-26
07613327648492Instrument5533-T-814-L5533-T-814-L2026-02-26
07613327651485Instrument5533-T-010-R5533-T-010-R2026-02-26
07613327651492Instrument5533-T-012-R5533-T-012-R2026-02-26
07613327651508Instrument5533-T-016-R5533-T-016-R2026-02-26
07613327651515Instrument5533-T-011-L5533-T-011-L2026-02-26
07613327651522Instrument5533-T-014-L5533-T-014-L2026-02-26
07613327651539Instrument5533-T-009-L5533-T-009-L2026-02-26
07613327651546Instrument5533-T-016-L5533-T-016-L2026-02-26

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