Home GUDID E314KNMCO010201 Bespoke
Primary DI E314KNMCO010201
Brand Bespoke
Company MATERIALISE USA, L.L.C.
Model KNM-CO01-02-01
Catalog number KNM-CO01-02-01
Device description Consensus MRI TKA tibia guide
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
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer OIY Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive OOG Knee Arthroplasty Implantation System
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic 2 MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer Orthopedic 2 OIY Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive Orthopedic 2 OOG Knee Arthroplasty Implantation System Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status E314KNMCO010201 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Custom-made orthopaedic/craniofacial surgical guide A custom-made surgical instrument intended to be used in an orthopaedic and/or craniomaxillofacial procedure (e.g., osteotomy, arthroplasty, tumour resection, distraction osteogenesis, cranial vault reconstruction) to assist in the intraoperative orientation of implant components, outlining the desired cut-line, and/or guiding of surgical instruments (e.g., surgical drill, oscillating cutting saw). It is typically 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.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 946657160 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00840097536705 Identity CR KA Restor3d, Inc. OIY 2026-09-25 00840097536705 Identity CR KA Restor3d, Inc. JWH 2026-09-25 00840097536705 Identity CR KA Restor3d, Inc. OOG 2026-09-25 00840097536712 Identity CR KA Restor3d, Inc. OOG 2026-09-25 00840097536712 Identity CR KA Restor3d, Inc. OIY 2026-09-25 00840097536712 Identity CR KA Restor3d, Inc. JWH 2026-09-25 00840097536729 Identity CR KA 3DP Porous Restor3d, Inc. OOG 2026-09-25 00840097536729 Identity CR KA 3DP Porous Restor3d, Inc. OIY 2026-09-25 00840097536729 Identity CR KA 3DP Porous Restor3d, Inc. JWH 2026-09-25 00840097536729 Identity CR KA 3DP Porous Restor3d, Inc. MBH 2026-09-25 00840097536736 Identity CR KA 3DP Porous Restor3d, Inc. OOG 2026-09-25 00840097536736 Identity CR KA 3DP Porous Restor3d, Inc. OIY 2026-09-25 00840097536736 Identity CR KA 3DP Porous Restor3d, Inc. JWH 2026-09-25 00840097536736 Identity CR KA 3DP Porous Restor3d, Inc. MBH 2026-09-25 00840097536743 Identity CR KA 3DP Porous Restor3d, Inc. OIY 2026-09-25 00840097536743 Identity CR KA 3DP Porous Restor3d, Inc. MBH 2026-09-25 00840097536743 Identity CR KA 3DP Porous Restor3d, Inc. JWH 2026-09-25 00840097536743 Identity CR KA 3DP Porous Restor3d, Inc. OOG 2026-09-25 00840097536750 Identity CR KA 3DP Porous Restor3d, Inc. OOG 2026-09-25 00840097536750 Identity CR KA 3DP Porous Restor3d, Inc. OIY 2026-09-25 00840097536750 Identity CR KA 3DP Porous Restor3d, Inc. JWH 2026-09-25 00840097536750 Identity CR KA 3DP Porous Restor3d, Inc. MBH 2026-09-25 00840097536767 Identity CR KA 3DP Porous Restor3d, Inc. OOG 2026-09-25 00840097536767 Identity CR KA 3DP Porous Restor3d, Inc. OIY 2026-09-25 00840097536767 Identity CR KA 3DP Porous Restor3d, Inc. JWH 2026-09-25 00840097536767 Identity CR KA 3DP Porous Restor3d, Inc. MBH 2026-09-25 00840097536774 Identity CR KA 3DP Porous Restor3d, Inc. OOG 2026-09-25 00840097536774 Identity CR KA 3DP Porous Restor3d, Inc. OIY 2026-09-25 00840097536774 Identity CR KA 3DP Porous Restor3d, Inc. JWH 2026-09-25 00840097536774 Identity CR KA 3DP Porous Restor3d, Inc. MBH 2026-09-25