FDA.reportPublic FDA data

ACO Planner

Primary DI
E314ACOPLANNER0
Brand
ACO Planner
Company
Materialise NV
Model
ACO Planner
Catalog number
ACO Planner
Device description
ACO Planner
Published
2017-02-10
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
PLWAcetabular Cup Orientation System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PLWAcetabular Cup Orientation SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150780000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150780000Acetabular Cup Orientation SystemMaterialise NV2015-10-27PLW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E314ACOPLANNER0PrimaryHIBCC0

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
373139427
Device count
1
Lot or batch
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
09351327000374OPS™ FHAOPTIMIZED ORTHO PTY LTDPLW2019-11-11
E314HPCCO0100010BespokeMATERIALISE USA, L.L.C.PLW2017-07-21
E314HPCCO0101010BespokeMATERIALISE USA, L.L.C.PLW2017-07-21
E314HPCCO0102010BespokeMATERIALISE USA, L.L.C.PLW2017-07-21
E314O02055700000113000SurgiCaseMaterialise NVPLW2017-07-21
E314HPCCO010001BespokeMATERIALISE USA, L.L.C.PLW2016-09-24
E314HPCCO010101BespokeMATERIALISE USA, L.L.C.PLW2016-09-24
E314HPCCO010201BespokeMATERIALISE USA, L.L.C.PLW2016-09-24
E314O0205570000011300SurgiCaseMaterialise NVPLW2016-09-24