Bespoke HPC-CO01-00-01

GUDID E314HPCCO010001

Consensus CT THA guides and bone models

MATERIALISE USA, L.L.C.

Custom-made organ/bone anatomy model/surgical guide kit
Primary Device IDE314HPCCO010001
NIH Device Record Key3546a269-5c2c-4eef-bca8-8bd828938f25
Commercial Distribution Discontinuation2017-07-21
Commercial Distribution StatusNot in Commercial Distribution
Brand NameBespoke
Version Model NumberHPC-CO01-00-01
Catalog NumberHPC-CO01-00-01
Company DUNS946657160
Company NameMATERIALISE USA, L.L.C.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCE314HPCCO010001 [Previous]
HIBCCE314HPCCO0100010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PLWAcetabular Cup Orientation System

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[E314HPCCO010001]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-11-27
Device Publish Date2016-09-24

On-Brand Devices [Bespoke]

E314KNMCO0600010Consensus MRI TKA tibia guide and bone model
E314KNMCO060001Consensus MRI TKA tibia guide and bone model
E314KNMCO0500010Consensus MRI TKA tibia guide and bone model
E314KNMCO050001Consensus MRI TKA tibia guide and bone model
E314KNMCO0300010Consensus MRI TKA femur guide and bone model
E314KNMCO030001Consensus MRI TKA femur guide and bone model
E314KNMCO0104010Consensus MRI TKA tibia bone model
E314KNMCO010401Consensus MRI TKA tibia bone model
E314KNMCO0103010Consensus MRI TKA femur bone model
E314KNMCO010301Consensus MRI TKA femur bone model
E314KNMCO0100010Consensus MRI TKA guides and bone models
E314KNMCO010001Consensus MRI TKA guides and bone models
E314HPCCO0102010Consensus CT THA hip bone model
E314HPCCO010201Consensus CT THA hip bone model
E314HPCCO010101Consensus CT THA hip guide
E314HPCCO010001Consensus CT THA guides and bone models
E314KNMCO0400010Consensus MRI TKA femur guide only
E314KNMCO040001Consensus MRI TKA femur guide only
E314KNMCO0200010Consensus MRI TKA guides
E314KNMCO020001Consensus MRI TKA guides
E314KNMCO0102010Consensus MRI TKA tibia guide
E314KNMCO010201Consensus MRI TKA tibia guide
E314KNMCO0101010Consensus MRI TKA femur guide
E314KNMCO010101Consensus MRI TKA femur guide

Trademark Results [Bespoke]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BESPOKE
BESPOKE
98685690 not registered Live/Pending
Bespoke Group Unlimited LLC
2024-08-06
BESPOKE
BESPOKE
98475479 not registered Live/Pending
Ryan J. Thompson, DDS, P.A.
2024-03-29
BESPOKE
BESPOKE
98372847 not registered Live/Pending
CAPITOL BEDDING CO. INC.
2024-01-24
BESPOKE
BESPOKE
98209012 not registered Live/Pending
Sun Served, LLC
2023-10-04
BESPOKE
BESPOKE
98019774 not registered Live/Pending
DESARROLLOS SEMPITERNO, S.A. DE C.V.
2023-05-30
BESPOKE
BESPOKE
97804282 not registered Live/Pending
McNair Interests Ltd.
2023-02-21
BESPOKE
BESPOKE
97656817 not registered Live/Pending
DELUXE HOME USA LLC
2022-11-01
BESPOKE
BESPOKE
97315333 not registered Live/Pending
Martin Rockwell
2022-03-16
BESPOKE
BESPOKE
90874333 not registered Live/Pending
Andis Company
2021-08-10
BESPOKE
BESPOKE
90510489 not registered Live/Pending
BESPOKE LUXURY MARKETING, LLC
2021-02-04
BESPOKE
BESPOKE
90339330 not registered Live/Pending
JAWHP, LLC
2020-11-24
BESPOKE
BESPOKE
90339329 not registered Live/Pending
JAWHP, LLC
2020-11-24

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