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 ID: E314HPCCO010001
• NIH Device Record Key: 3546a269-5c2c-4eef-bca8-8bd828938f25
• Commercial Distribution Discontinuation: 2017-07-21
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Bespoke
• Version Model Number: HPC-CO01-00-01
• Catalog Number: HPC-CO01-00-01
• Company DUNS: 946657160
• Company Name: MATERIALISE USA, L.L.C.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E314HPCCO010001 [Previous]
HIBCC	E314HPCCO0100010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150780

FDA Product Code

• PLW: Acetabular Cup Orientation System

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[E314HPCCO010001]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-11-27
• Device Publish Date: 2016-09-24

On-Brand Devices [Bespoke]

• E314KNMCO0600010: Consensus MRI TKA tibia guide and bone model
• E314KNMCO060001: Consensus MRI TKA tibia guide and bone model
• E314KNMCO0500010: Consensus MRI TKA tibia guide and bone model
• E314KNMCO050001: Consensus MRI TKA tibia guide and bone model
• E314KNMCO0300010: Consensus MRI TKA femur guide and bone model
• E314KNMCO030001: Consensus MRI TKA femur guide and bone model
• E314KNMCO0104010: Consensus MRI TKA tibia bone model
• E314KNMCO010401: Consensus MRI TKA tibia bone model
• E314KNMCO0103010: Consensus MRI TKA femur bone model
• E314KNMCO010301: Consensus MRI TKA femur bone model
• E314KNMCO0100010: Consensus MRI TKA guides and bone models
• E314KNMCO010001: Consensus MRI TKA guides and bone models
• E314HPCCO0102010: Consensus CT THA hip bone model
• E314HPCCO010201: Consensus CT THA hip bone model
• E314HPCCO010101: Consensus CT THA hip guide
• E314HPCCO010001: Consensus CT THA guides and bone models
• E314KNMCO0400010: Consensus MRI TKA femur guide only
• E314KNMCO040001: Consensus MRI TKA femur guide only
• E314KNMCO0200010: Consensus MRI TKA guides
• E314KNMCO020001: Consensus MRI TKA guides
• E314KNMCO0102010: Consensus MRI TKA tibia guide
• E314KNMCO010201: Consensus MRI TKA tibia guide
• E314KNMCO0101010: Consensus MRI TKA femur guide
• E314KNMCO010101: Consensus MRI TKA femur guide