Zimmer Patient Specific Instruments 00-5970-000-19

GUDID E314005970000190

N-K Flex Pin Guides (Femur and Tibia) CT

Materialise NV

Custom-made organ/bone anatomy model/surgical guide kit
Primary Device IDE314005970000190
NIH Device Record Key1e8cdf8a-be1e-4a57-87e1-d9b364bd8b35
Commercial Distribution Discontinuation2019-03-01
Commercial Distribution StatusNot in Commercial Distribution
Brand NameZimmer Patient Specific Instruments
Version Model Number00-5970-000-19
Catalog Number00-5970-000-19
Company DUNS373139427
Company NameMaterialise NV
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 Datefalse
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
HIBCCE31400597000019 [Previous]
HIBCCE314005970000190 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[E314005970000190]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-11-27
Device Publish Date2017-07-21

On-Brand Devices [Zimmer Patient Specific Instruments]

E314005970000480PERSONATM PREF PS Pin Guides (Femur and Tibia) CT
E314005970000450PERSONATM PREF CR Pin Guides (Femur and Tibia) CT
E314005970000420PERSONATM PS Pin Guides (Femur and Tibia) CT
E31400597000039000-5970-000-39
E314005970000360PERSONA PREF PS Pin Guides (Femur and Tibia)
E314005970000330PERSONA PREF CR Pin Guides (Femur and Tibia)
E314005970000290PERSONA PS Pin Guides (Femur and Tibia)
E314005970000250PERSONA CR Pin Guides (Femur and Tibia)
E314005970000190N-K Flex Pin Guides (Femur and Tibia) CT
E31400597000018000-5970-000-18
E314005970000170NexGen® LPS Pin Guides (Femur and Tibia) CT
E314005970000160NexGen® CR-FLEX PIN GUIDES (FEMUR AND TIBIA) CT
E314005970000150NexGen® CR Pin Guides (Femur and Tibia) CT
E314005970000140NexGen® LPS Pin Guides (Femur and Tibia)
E314005970000130NexGen® CR Pin Guides (Femur and Tibia)
E31400597000010000-5970-000-10
E314005970000040Unicompartmental High Flex Knee (Femur and Tibia)
E314005970000030N-K Flex Pin Guides (Femur and Tibia)
E314005970000020NexGen® LPS-FLEX PIN GUIDES (FEMUR AND TIBIA)
E314005970000010NexGen® CR-FLEX PIN GUIDES (FEMUR AND TIBIA)
E31400597000048PERSONATM PREF PS Pin Guides (Femur and Tibia) CT
E31400597000045PERSONATM PREF CR Pin Guides (Femur and Tibia) CT
E31400597000042PERSONATM PS Pin Guides (Femur and Tibia) CT
E3140059700003600-5970-000-36
E3140059700003300-5970-000-33
E3140059700002900-5970-000-29
E3140059700002500-5970-000-25
E31400597000019N-K Flex Pin Guides (Femur and Tibia) CT
E3140059700001800-5970-000-18
E31400597000017NexGen® LPS Pin Guides (Femur and Tibia) CT
E3140059700001600-5970-000-16
E31400597000015NexGen® CR Pin Guides (Femur and Tibia) CT
E31400597000014NexGen® LPS Pin Guides (Femur and Tibia)
E31400597000013NexGen® CR Pin Guides (Femur and Tibia)
E31400597000004Unicompartmental High Flex Knee (Femur and Tibia)
E31400597000003N-K Flex Pin Guides (Femur and Tibia)
E3140059700000200-5970-000-02
E3140059700000100-5970-000-01

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