FREEDOM KNEE CEMENTLESS

GUDID 00811767025164

Cementless Femoral Size B, PS, Right

MAXX ORTHOPEDICS, INC.

Coated knee femur prosthesis Coated knee femur prosthesis

• Primary Device ID: 00811767025164
• NIH Device Record Key: 20201420-2836-45ae-8279-b47d51394a50
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FREEDOM KNEE CEMENTLESS
• Version Model Number: PFPSRB00-PK
• Company DUNS: 792030103
• Company Name: MAXX ORTHOPEDICS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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 Dimensions

• Length: 54 Millimeter
• Length: 54 Millimeter
• Length: 54 Millimeter
• Length: 54 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811767025164 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150680

FDA Product Code

• MBH: Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, 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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-13

On-Brand Devices [FREEDOM KNEE CEMENTLESS]

• 00811767025225: Cementless Femoral Size H, PS, Right
• 00811767025218: Cementless Femoral Size G, PS, Right
• 00811767025201: Cementless Femoral Size F, PS, Right
• 00811767025195: Cementless Femoral Size E, PS, Right
• 00811767025188: Cementless Femoral Size D, PS, Right
• 00811767025171: Cementless Femoral Size C, PS, Right
• 00811767025164: Cementless Femoral Size B, PS, Right
• 00811767025157: Cementless Femoral Size A, PS, Right
• 00811767025140: Cementless Femoral Size H, PS, Left
• 00811767025133: Cementless Femoral Size G, PS, Left
• 00811767025126: Cementless Femoral Size F, PS, Left
• 00811767025119: Cementless Femoral Size E, PS, Left
• 00811767025102: Cementless Femoral Size D, PS, Left
• 00811767025096: Cementless Femoral Size C, PS, Left
• 00811767025089: Cementless Femoral Size B, PS, Left
• 00811767025072: Cementless Femoral Size A, PS, Left
• 00811767025065: Cementless Femoral Size H, CR, Right
• 00811767025058: Cementless Femoral Size G, CR, Right
• 00811767025041: Cementless Femoral Size F, CR, Right
• 00811767025034: Cementless Femoral Size E, CR, Right
• 00811767025027: Cementless Femoral Size D, CR, Right
• 00811767025010: Cementless Femoral Size C, CR, Right
• 00811767025003: Cementless Femoral Size B, CR, Right
• 00811767024990: Cementless Femoral Size A, CR, Right
• 00811767024983: Cementless Femoral Size H, CR, Left
• 00811767024976: Cementless Femoral Size G, CR, Left
• 00811767024969: Cementless Femoral Size F, CR, Left
• 00811767024952: Cementless Femoral Size E, CR, Left
• 00811767024945: Cementless Femoral Size D, CR, Left
• 00811767024938: Cementless Femoral Size C, CR, Left
• 00811767024921: Cementless Femoral Size B, CR, Left
• 00811767024914: Cementless Femoral Size A, CR, Left