FDA.reportPublic FDA data

Bespoke

Primary DI
E314HPCCO010001
Brand
Bespoke
Company
MATERIALISE USA, L.L.C.
Model
HPC-CO01-00-01
Catalog number
HPC-CO01-00-01
Device description
Consensus CT THA guides and bone models
Published
2016-09-24
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
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
E314HPCCO010001PreviousHIBCC0
E314HPCCO0100010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Custom-made organ/bone anatomy model/surgical guide kitA collection of custom-made devices intended to be used to assist anatomical visualization, surgical treatment planning, and intraoperative surgical procedures (e.g., orientation of implant components, guiding of surgical instruments). It consists of an anatomy model(s) of an organ/bone and an orthopaedic/craniomaxillofacial surgical guide(s) [e.g., for osteotomy, arthroplasty]; it is made of synthetic polymer materials and is manufactured by 3-D printing and CAD/CAM techniques to match the patient-specific contours of the target anatomical site. This is a single-use device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
946657160
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
E314KNMCO010301BespokeKNM-CO01-03-01KNM-CO01-03-012016-09-24
E314KNMCO0103010BespokeKNM-CO01-03-01KNM-CO01-03-012017-07-21
E314KNMCO010401BespokeKNM-CO01-04-01KNM-CO01-04-012016-09-24
E314KNMCO0104010BespokeKNM-CO01-04-01KNM-CO01-04-012017-07-21
E314KNMCO010101BespokeKNM-CO01-01-01KNM-CO01-01-012016-09-24
E314KNMCO0101010BespokeKNM-CO01-01-01KNM-CO01-01-012017-07-21
E314KNMCO010201BespokeKNM-CO01-02-01KNM-CO01-02-012016-09-24
E314KNMCO0102010BespokeKNM-CO01-02-01KNM-CO01-02-012017-07-21
E314KNMCO020001BespokeKNM-CO02-00-01KNM-CO02-00-012016-09-24
E314KNMCO0200010BespokeKNM-CO02-00-01KNM-CO02-00-012017-07-21
E314KNMCO040001BespokeKNM-CO04-00-01KNM-CO04-00-012016-09-24
E314KNMCO0400010BespokeKNM-CO04-00-01KNM-CO04-00-012017-07-21
E314HPCCO0100010BespokeHPC-CO01-00-01HPC-CO01-00-012017-07-21
E314HPCCO0101010BespokeHPC-CO01-01-01HPC-CO01-01-012017-07-21
E314HPCCO010101BespokeHPC-CO01-01-01HPC-CO01-01-012016-09-24
E314HPCCO010201BespokeHPC-CO01-02-01HPC-CO01-02-012016-09-24
E314HPCCO0102010BespokeHPC-CO01-02-01HPC-CO01-02-012017-07-21
E314KNMCO010001BespokeKNM-CO01-00-01KNM-CO01-00-012016-09-24
E314KNMCO0100010BespokeKNM-CO01-00-01KNM-CO01-00-012017-07-21
E314KNMCO030001BespokeKNM-CO03-00-01KNM-CO03-00-012016-09-24

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
E314ACOPLANNER0ACO Planner Materialise NVPLW2017-02-10
E314HPCCO010101BespokeMATERIALISE USA, L.L.C.PLW2016-09-24
E314HPCCO010201BespokeMATERIALISE USA, L.L.C.PLW2016-09-24
E314O0205570000011300SurgiCaseMaterialise NVPLW2016-09-24