FDA.reportPublic FDA data

Vantage

Primary DI
10885862609403
Brand
Vantage
Company
Exactech, Inc.
Model
351-22-35
Catalog number
351-22-35
Device description
LNR TRIAL-FB-SZ 5-R-9MM
Published
2022-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HWTTEMPLATE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWTTemplateOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10885862609403PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088586260940310885862609403

GMDN Terms#

Term, Definition table
TermDefinition
Ankle prosthesis trialA copy of a final prosthesis designed to be used during ankle replacement surgery to determine the correct alignment, size, and fit of the final tibial, talar or bearing prosthesis component. It is one of a set, or a set, of graduated sizes and is typically made of synthetic polymer or metal material. This is a reusable device intended to be sterilized prior to use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Height9Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
157565946
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885862032102Novation160-20-11160-20-112015-08-10
10885862064035Optetrak244-24-09244-24-092015-10-30
10885862307132Truliant02-022-49-251102-022-49-25112017-05-16
10885862313058Optetrak Logic02-012-44-260902-012-44-26092017-02-16
10885862313065Optetrak Logic02-012-44-261102-012-44-26112017-02-16
10885862313072Optetrak Logic02-012-44-261302-012-44-26132017-02-16
10885862313089Optetrak Logic02-012-44-261502-012-44-26152017-02-16
10885862313218Optetrak Logic02-012-35-210902-012-35-21092017-02-16
10885862313225Optetrak Logic02-012-35-211102-012-35-21112017-02-16
10885862313232Optetrak Logic02-012-35-211302-012-35-21132017-02-16
10885862316271Optetrak Logic02-012-35-211702-012-35-21172017-02-16
10885862316288Optetrak Logic02-012-35-211902-012-35-21192017-02-16
10885862316356Optetrak Logic02-012-44-261702-012-44-26172017-02-16
10885862316363Optetrak Logic02-012-44-261902-012-44-26192017-02-16
10885862135049NAT2-5052T2-50522022-09-19
10885862135056NAT2-5458T2-54582022-09-19
10885862135063NAT2-6064T2-60642022-09-19
10885862135070NAT2-6670T2-66702022-09-19
10885862135636NAT8-4448T8-44482022-09-19
10885862135643NAT8-5052T8-50522022-09-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10603295553588ATTUNEDEPUY ORTHOPAEDICS, INC.HWT2026-08-26
10603295553595ATTUNEDEPUY ORTHOPAEDICS, INC.HWT2026-08-26
10603295553601ATTUNEDEPUY ORTHOPAEDICS, INC.HWT2026-08-26
10603295553618ATTUNEDEPUY ORTHOPAEDICS, INC.HWT2026-08-26
10705034579900N/AMedos International SàrlHWT2026-08-26
10705034579917N/AMedos International SàrlHWT2026-08-26
10705034579924N/AMedos International SàrlHWT2026-08-26
00889024711464Comp Mini Humeral Tray Trial Stem AdapterZimmer, Inc.HWT2026-08-25
00889024713277Universal Uni Knee TensorZimmer, Inc.HWT2026-08-25
00889024713284Right Uni Knee TensorZimmer, Inc.HWT2026-08-25
00889024713291Left Uni Knee TensorZimmer, Inc.HWT2026-08-25
00860009784925Flap Marking TemplateMirrorme3d, LLCHWT2023-03-17
00860009784918TemplateMirrorme3d, LLCHWT2023-02-16
00885556841532XT Revision Ankle Replacement SystemSmith & Nephew, Inc.HWT2023-02-02
00885556841549XT Revision Ankle Replacement SystemSmith & Nephew, Inc.HWT2023-02-02
00885556841556XT Revision Ankle Replacement SystemSmith & Nephew, Inc.HWT2023-02-02
00885556841563XT Revision Ankle Replacement SystemSmith & Nephew, Inc.HWT2023-02-02
00885556841570XT Revision Ankle Replacement SystemSmith & Nephew, Inc.HWT2023-02-02
00885556841587XT Revision Ankle Replacement SystemSmith & Nephew, Inc.HWT2023-02-02
00885556841594XT Revision Ankle Replacement SystemSmith & Nephew, Inc.HWT2023-02-02
00885556841600XT Revision Ankle Replacement SystemSmith & Nephew, Inc.HWT2023-02-02
00885556841655XT Revision Ankle Replacement SystemSmith & Nephew, Inc.HWT2023-02-02
00885556841662XT Revision Ankle Replacement SystemSmith & Nephew, Inc.HWT2023-02-02
00885556841679XT Revision Ankle Replacement SystemSmith & Nephew, Inc.HWT2023-02-02
00885556841686XT Revision Ankle Replacement SystemSmith & Nephew, Inc.HWT2023-02-02
00885556841693XT Revision Ankle Replacement SystemSmith & Nephew, Inc.HWT2023-02-02
00885556841709XT Revision Ankle Replacement SystemSmith & Nephew, Inc.HWT2023-02-02
00885556841716XT Revision Ankle Replacement SystemSmith & Nephew, Inc.HWT2023-02-02
00885556841723XT Revision Ankle Replacement SystemSmith & Nephew, Inc.HWT2023-02-02
00885556841730XT Revision Ankle Replacement SystemSmith & Nephew, Inc.HWT2023-02-02