FDA.reportPublic FDA data

VISIONAIRE UNI

Primary DI
00885556700167
Brand
VISIONAIRE UNI
Company
Materialise NV
Model
V0500001
Catalog number
V0500001
Device description
NONSTERILE VISIONAIRE UNI CUTTING GUIDE
Published
2018-04-10
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172650000
K173970000
K202207000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172650000Materialise PKA Guide SystemMaterialise NV2017-11-20HSX
K173970000Materialise PKA Guide SystemMaterialise NV2018-07-06HSX
K202207000Materialise PKA Guide SystemMaterialise NV2020-10-02HSX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885556700167PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885556700167008855567001678855567001670885556700167

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
373139427
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05404028001394SurgiCase Shoulder PlannerSurgiCase Shoulder PlannerSurgiCase Shoulder Planner2026-11-03
05404028001370Mimics Cardiac PlannerMimics Cardiac Planner TAVRMimics Cardiac Planner TAVR2026-10-30
05420060351235TRUMATCHSD980.041SD980.0412026-10-22
05420060351242TRUMATCHSD980.042SD980.0422026-10-22
05420060351259TRUMATCHSD980.043SD980.0432026-10-22
05420060351266TRUMATCHSD980.044SD980.0442026-10-22
05420060351273TRUMATCHSD980.045SD980.0452026-10-22
05420060351280TRUMATCHSD980.046SD980.0462026-10-22
05420060351297TRUMATCHSD980.047SD980.0472026-10-22
05420060351303TRUMATCHSD980.048SD980.0482026-10-22
05420060351310TRUMATCHSD980.049SD980.0492026-10-22
05420060351327TRUMATCHSD980.050SD980.0502026-10-22
05420060351334TRUMATCHSD980.051SD980.0512026-10-22
05420060351341TRUMATCHSD980.052SD980.0522026-10-22
05420060351358TRUMATCHSD980.053SD980.0532026-10-22
05420060351365TRUMATCHSD980.054SD980.0542026-10-22
05420060351372TRUMATCHSD980.055SD980.0552026-10-22
05420060351389TRUMATCHSD980.056SD980.0562026-10-22
05420060351396TRUMATCHSD980.057SD980.0572026-10-22
05420060351402TRUMATCHSD980.058SD980.0582026-10-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810129550009OvertureTiOverture Resurfacing IncHSX2026-10-18
00810129550023OvertureTiOverture Resurfacing IncHSX2026-10-18
00810129550030OvertureTiOverture Resurfacing IncHSX2026-10-18
00810129550047OvertureTiOverture Resurfacing IncHSX2026-10-18
00810129550061OvertureTiOverture Resurfacing IncHSX2026-10-18
00810129550078OvertureTiOverture Resurfacing IncHSX2026-10-18
00810129550085OvertureTiOverture Resurfacing IncHSX2026-10-18
00810129550108OvertureTiOverture Resurfacing IncHSX2026-10-18
00810129550115OvertureTiOverture Resurfacing IncHSX2026-10-18
00810129550122OvertureTiOverture Resurfacing IncHSX2026-10-18
00810129550139OvertureTiOverture Resurfacing IncHSX2026-10-18
05404028001257SurgiCase PlannerMaterialise NVHSX2026-05-28
05404028000922SurgiCase PlannerMaterialise NVHSX2025-05-14
00822409130153N/AOrtho Development CorporationHSX2025-03-17
00822409130160N/AOrtho Development CorporationHSX2025-03-17
00822409130177N/AOrtho Development CorporationHSX2025-03-17
00822409130184N/AOrtho Development CorporationHSX2025-03-17
00822409130191N/AOrtho Development CorporationHSX2025-03-17
00822409130207N/AOrtho Development CorporationHSX2025-03-17
00822409130214N/AOrtho Development CorporationHSX2025-03-17
00822409130221N/AOrtho Development CorporationHSX2025-03-17
00822409130238N/AOrtho Development CorporationHSX2025-03-17
00822409130245N/AOrtho Development CorporationHSX2025-03-17
00822409130252N/AOrtho Development CorporationHSX2025-03-17
00822409130269N/AOrtho Development CorporationHSX2025-03-17
00810129550221OvertureTiOverture Resurfacing IncHSX2024-12-06
00810129550238OvertureTiOverture Resurfacing IncHSX2024-12-06
00810129550245OvertureTiOverture Resurfacing IncHSX2024-12-06
00810129550016OvertureTiOverture Resurfacing IncHSX2023-10-18
00810129550054OvertureTiOverture Resurfacing IncHSX2023-10-18