Bespoke KNM-CO03-00-01

GUDID E314KNMCO0300010

Consensus MRI TKA femur guide and bone model

MATERIALISE USA, L.L.C.

Custom-made organ/bone anatomy model/surgical guide kit

• Primary Device ID: E314KNMCO0300010
• NIH Device Record Key: f139802b-65ac-46e7-98f5-d205b0492892
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bespoke
• Version Model Number: KNM-CO03-00-01
• Catalog Number: KNM-CO03-00-01
• 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	E314KNMCO030001 [Previous]
HIBCC	E314KNMCO0300010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150928

FDA Product Code

• JWH: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Sterilization

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

[E314KNMCO0300010]

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: 2017-07-21

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