Zimmer Patient Specific Instruments 00-5970-000-16

GUDID E314005970000160

NexGen® CR-FLEX PIN GUIDES (FEMUR AND TIBIA) CT

Materialise NV

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

• Primary Device ID: E314005970000160
• NIH Device Record Key: 7223da6a-ee02-4c61-a8f0-78695f4f5620
• Commercial Distribution Discontinuation: 2019-03-01
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Zimmer Patient Specific Instruments
• Version Model Number: 00-5970-000-16
• Catalog Number: 00-5970-000-16
• Company DUNS: 373139427
• Company Name: Materialise NV
• 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: false
• 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	E31400597000016 [Previous]
HIBCC	E314005970000160 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113829

FDA Product Code

• MBH: Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer

Sterilization

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

[E314005970000160]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-11-27
• Device Publish Date: 2017-07-21

On-Brand Devices [Zimmer Patient Specific Instruments]

• E314005970000480: PERSONATM PREF PS Pin Guides (Femur and Tibia) CT
• E314005970000450: PERSONATM PREF CR Pin Guides (Femur and Tibia) CT
• E314005970000420: PERSONATM PS Pin Guides (Femur and Tibia) CT
• E314005970000390: 00-5970-000-39
• E314005970000360: PERSONA PREF PS Pin Guides (Femur and Tibia)
• E314005970000330: PERSONA PREF CR Pin Guides (Femur and Tibia)
• E314005970000290: PERSONA PS Pin Guides (Femur and Tibia)
• E314005970000250: PERSONA CR Pin Guides (Femur and Tibia)
• E314005970000190: N-K Flex Pin Guides (Femur and Tibia) CT
• E314005970000180: 00-5970-000-18
• E314005970000170: NexGen® LPS Pin Guides (Femur and Tibia) CT
• E314005970000160: NexGen® CR-FLEX PIN GUIDES (FEMUR AND TIBIA) CT
• E314005970000150: NexGen® CR Pin Guides (Femur and Tibia) CT
• E314005970000140: NexGen® LPS Pin Guides (Femur and Tibia)
• E314005970000130: NexGen® CR Pin Guides (Femur and Tibia)
• E314005970000100: 00-5970-000-10
• E314005970000040: Unicompartmental High Flex Knee (Femur and Tibia)
• E314005970000030: N-K Flex Pin Guides (Femur and Tibia)
• E314005970000020: NexGen® LPS-FLEX PIN GUIDES (FEMUR AND TIBIA)
• E314005970000010: NexGen® CR-FLEX PIN GUIDES (FEMUR AND TIBIA)
• E31400597000048: PERSONATM PREF PS Pin Guides (Femur and Tibia) CT
• E31400597000045: PERSONATM PREF CR Pin Guides (Femur and Tibia) CT
• E31400597000042: PERSONATM PS Pin Guides (Femur and Tibia) CT
• E31400597000036: 00-5970-000-36
• E31400597000033: 00-5970-000-33
• E31400597000029: 00-5970-000-29
• E31400597000025: 00-5970-000-25
• E31400597000019: N-K Flex Pin Guides (Femur and Tibia) CT
• E31400597000018: 00-5970-000-18
• E31400597000017: NexGen® LPS Pin Guides (Femur and Tibia) CT
• E31400597000016: 00-5970-000-16
• E31400597000015: NexGen® CR Pin Guides (Femur and Tibia) CT
• E31400597000014: NexGen® LPS Pin Guides (Femur and Tibia)
• E31400597000013: NexGen® CR Pin Guides (Femur and Tibia)
• E31400597000004: Unicompartmental High Flex Knee (Femur and Tibia)
• E31400597000003: N-K Flex Pin Guides (Femur and Tibia)
• E31400597000002: 00-5970-000-02
• E31400597000001: 00-5970-000-01