FDA.reportPublic FDA data

INBONE

Primary DI
00889797048392
Brand
INBONE
Company
WRIGHT MEDICAL TECHNOLOGY, INC.
Model
IB204310
Catalog number
IB204310
Published
2016-09-17
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

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889797048392PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889797048392008897970483928897970483920889797048392

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
Height10Millimeter

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
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
true
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
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
00889797023368INVISION600022012016-09-17
00889797023375INVISION600023002016-09-17
00889797023382INVISION600023012016-09-17
00889797023436INVISION600025002016-09-17
00889797023337INVISION600021002016-09-17
00889797023344INVISION600021012016-09-17
00889797023351INVISION600022002016-09-17
00889797107679Made-To-OrderSMS00456SMS004562022-12-08
00889797108188Made-To-OrderSMS00494SMS004942022-12-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10885862655714VantageExactech, Inc.HSN2026-03-19
10885862656834VantageExactech, Inc.HSN2026-03-10
10885862656841VantageExactech, Inc.HSN2026-03-10
10885862656858VantageExactech, Inc.HSN2026-03-10
10885862656865VantageExactech, Inc.HSN2026-03-10
10885862656872VantageExactech, Inc.HSN2026-03-10
10885862656889VantageExactech, Inc.HSN2026-03-10
10885862656896VantageExactech, Inc.HSN2026-03-10
10885862656902VantageExactech, Inc.HSN2026-03-10
10885862656919VantageExactech, Inc.HSN2026-03-10
10885862656926VantageExactech, Inc.HSN2026-03-10
10885862656933VantageExactech, Inc.HSN2026-03-10
10885862656940VantageExactech, Inc.HSN2026-03-10
00889795154026APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HSN2026-02-19
00840097533681Kinos Total Ankle InstrumentationRestor3d, Inc.HSN2025-12-12
00840097533698Kinos Total Ankle InstrumentationRestor3d, Inc.HSN2025-12-12
00840097533704Kinos Total Ankle InstrumentationRestor3d, Inc.HSN2025-12-12
00840097535951Kinos Total Ankle InstrumentationRestor3d, Inc.HSN2025-12-12
00841731125385Hintermann Series VILEX LLCHSN2025-09-17
00841731125682Hintermann Series VILEX LLCHSN2025-09-17
00841731125736Hintermann Series VILEX LLCHSN2025-09-17
00841731125743Hintermann Series VILEX LLCHSN2025-09-17
00841731125750Hintermann Series VILEX LLCHSN2025-09-17
00841731125767Hintermann Series VILEX LLCHSN2025-09-17
00841731125989Hintermann Series VILEX LLCHSN2025-09-17
00841731125996Hintermann Series VILEX LLCHSN2025-09-17
00841731126009Hintermann Series VILEX LLCHSN2025-09-17
00841731126016Hintermann Series VILEX LLCHSN2025-09-17
00841731126023Hintermann Series VILEX LLCHSN2025-09-17
00841731126030Hintermann Series VILEX LLCHSN2025-09-17