INVISION

Primary DI
00840420194299
Brand
INVISION
Company
WRIGHT MEDICAL TECHNOLOGY, INC.
Model
60011050
Catalog number
60011050
Device description
Talar Plate Trial
Published
2018-02-14
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
HSNPROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSNProsthesis, Ankle, Semi-Constrained, Cemented, Metal/PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171067000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171067000INVISION Total Ankle Revision SystemWrightmedicaltechnologyinc2017-09-11HSN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840420194299PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840420194299008404201942998404201942990840420194299

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
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)238-7117customerservice@wmt.com

Regulatory Flags#

DUNS number
807201207
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
00889797076586INVISION60004403600044032022-05-31
00840420167606INVISION600044032016-02-26
00840420106254DARCODC0043162015-10-01
00840420106261DARCODC0043182015-10-01
00840420106278DARCODC0043202015-10-01
00840420106285DARCODC0043222015-10-01
00840420106292DARCODC0043242015-10-01
00889797023443INVISION600025012016-09-17
00889797024136INVISION600124002016-09-17
00889797024143INVISION600124012016-09-17
00889797040686NA49411XL2016-09-17
00889797040693NA49412XL2016-09-17
00889797040709NA49413XL2016-09-17
00889797057295EZ FRAMEEF0037002015-10-24
00889797058452EZ FRAME SIDEKICKEF0016002016-09-17
00889797102957NAEF002550EF0025502022-06-23
00889797103084NAEF003005EF0030052022-06-23
00889797103107NAEF003700EF0037002022-06-23
00889797103091NAEF003010EF0030102022-06-23
00889797103046NAEF001600EF0016002022-05-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10381780237730Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780237747Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780237754Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780237761Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780237778Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780237785Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780237792Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780237808Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780237815Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780237822Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780237839Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780237846Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780237853Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780237860Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780237877Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780237884Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780237891Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780237907Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780237914Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780237921Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780237938Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780237945Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780237952Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780237969Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780237976Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780237983Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780237990Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780238003Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780238010Cadence™Ascension Orthopedics, Inc.HSN2016-01-12
10381780238027Cadence™Ascension Orthopedics, Inc.HSN2016-01-12