ANATOMIC 1-0209501

GUDID 03701089500012

ANATOMIC® Posterior Stabilized Femoral Component Cemented Size 1 RIGHT

AMPLITUDE SAS

Uncoated knee femur prosthesis, metallic

• Primary Device ID: 03701089500012
• NIH Device Record Key: af5323a1-93e9-486f-9a44-b7b942f22e86
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ANATOMIC
• Version Model Number: 1-0209501
• Catalog Number: 1-0209501
• Company DUNS: 634855407
• Company Name: AMPLITUDE SAS
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +0033475418741
• Email: regulatoryaffairs@amplitude-ortho.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	03701089500012 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161414

FDA Product Code

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

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-12-11
• Device Publish Date: 2017-08-07

On-Brand Devices [ANATOMIC]

• 03701089500807: ANATOMIC® Tibial Base Plate for Fixed Bearing Insert Cemented Size 8
• 03701089500791: ANATOMIC® Tibial Base Plate for Fixed Bearing Insert Cemented Size 7
• 03701089500784: ANATOMIC® Tibial Base Plate for Fixed Bearing Insert Cemented Size 6
• 03701089500777: ANATOMIC® Tibial Base Plate for Fixed Bearing Insert Cemented Size 5
• 03701089500760: ANATOMIC® Tibial Base Plate for Fixed Bearing Insert Cemented Size 4
• 03701089500753: ANATOMIC® Tibial Base Plate for Fixed Bearing Insert Cemented Size 3
• 03701089500746: ANATOMIC® Tibial Base Plate for Fixed Bearing Insert Cemented Size 2
• 03701089500739: ANATOMIC® Tibial Base Plate for Fixed Bearing Insert Cemented Size 1
• 03701089500722: ANATOMIC® Tibial Base Plate for Fixed Bearing Insert Cemented Size 0
• 03701089500173: ANATOMIC® Posterior Stabilized Femoral Component Cemented Size 8 LEFT
• 03701089500166: ANATOMIC® Posterior Stabilized Femoral Component Cemented Size 7 LEFT
• 03701089500159: ANATOMIC® Posterior Stabilized Femoral Component Cemented Size 6 LEFT
• 03701089500142: ANATOMIC® Posterior Stabilized Femoral Component Cemented Size 5 LEFT
• 03701089500135: ANATOMIC® Posterior Stabilized Femoral Component Cemented Size 4 LEFT
• 03701089500128: ANATOMIC® Posterior Stabilized Femoral Component Cemented Size 3 LEFT
• 03701089500111: ANATOMIC® Posterior Stabilized Femoral Component Cemented Size 2 LEFT
• 03701089500104: ANATOMIC® Posterior Stabilized Femoral Component Cemented Size 1 LEFT
• 03701089500098: ANATOMIC® Posterior Stabilized Femoral Component Cemented Size 0 LEFT
• 03701089500081: ANATOMIC® Posterior Stabilized Femoral Component Cemented Size 8 RIGHT
• 03701089500074: ANATOMIC® Posterior Stabilized Femoral Component Cemented Size 7 RIGHT
• 03701089500067: ANATOMIC® Posterior Stabilized Femoral Component Cemented Size 6 RIGHT
• 03701089500050: ANATOMIC® Posterior Stabilized Femoral Component Cemented Size 5 RIGHT
• 03701089500043: ANATOMIC® Posterior Stabilized Femoral Component Cemented Size 4 RIGHT
• 03701089500036: ANATOMIC® Posterior Stabilized Femoral Component Cemented Size 3 RIGHT
• 03701089500029: ANATOMIC® Posterior Stabilized Femoral Component Cemented Size 2 RIGHT
• 03701089500012: ANATOMIC® Posterior Stabilized Femoral Component Cemented Size 1 RIGHT
• 03701089500005: ANATOMIC® Posterior Stabilized Femoral Component Cemented Size 0 RIGHT