FREEDOM STEMMED

GUDID 00811767024617

Tibial Augment Size 4

MAXX ORTHOPEDICS, INC.

Bicompartmental knee prosthesis

• Primary Device ID: 00811767024617
• NIH Device Record Key: ce9950ce-e553-4dbc-a9bc-598451639d40
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FREEDOM STEMMED
• Version Model Number: RAUUX400-RK
• 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: 42.2 Millimeter
• Length: 42.2 Millimeter
• Length: 42.2 Millimeter
• Length: 42.2 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811767024617 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111785

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-07

On-Brand Devices [FREEDOM STEMMED]

• 00811767025522: Stem Extension 20x150mm
• 00811767025515: Stem Extension 20x100mm
• 00811767025508: Stem Extension 20x75mm
• 00811767025492: Stem Extension 18x150mm
• 00811767025485: Stem Extension 18x100mm
• 00811767025478: Stem Extension 18x75mm
• 00811767024907: Tibial Augment Size 0
• 00811767024846: Augment Screw 15
• 00811767024839: Augment Screw 10
• 00811767024822: Augment Screw 5
• 00811767024815: Posterior Femoral Augment Size H
• 00811767024808: Posterior Femoral Augment Size G
• 00811767024792: Posterior Femoral Augment Size F
• 00811767024785: Posterior Femoral Augment Size E
• 00811767024761: Posterior Femoral Augment Size C
• 00811767024754: Posterior Femoral Augment Size B
• 00811767024730: Distal Femoral Augment Size H
• 00811767024723: Distal Femoral Augment Size G
• 00811767024716: Distal Femoral Augment Size F
• 00811767024709: Distal Femoral Augment Size E
• 00811767024686: Distal Femoral Augment Size C
• 00811767024679: Distal Femoral Augment Size B
• 00811767024655: Tibial Augment Size 8
• 00811767024648: Tibial Augment Size 7
• 00811767024631: Tibial Augment Size 6
• 00811767024624: Tibial Augment Size 5
• 00811767024617: Tibial Augment Size 4
• 00811767024600: Tibial Augment Size 3
• 00811767024594: Tibial Augment Size 2
• 00811767024587: Tibial Augment Size 1
• 00811767024570: Stem Extension 16.5x150mm
• 00811767024563: Stem Extension 16.5x100mm
• 00811767024556: Stem Extension 16.5x75mm
• 00811767024549: Stem Extension 15x150mm
• 00811767024532: Stem Extension 15x100mm
• 00811767024525: Stem Extension 15x75mm
• 00811767024518: Stem Extension 15x40mm
• 00811767024501: Stem Extension 13.5x150mm
• 00811767024495: Stem Extension 13.5x100mm
• 00811767024488: Stem Extension 13.5x75mm
• 00811767024471: Stem Extension 12x150mm
• 00811767024464: Stem Extension 12x100mm
• 00811767024457: Stem Extension 12x75mm
• 00811767024440: Stem Extension 12x40mm
• 00811767024433: Stem Extension 10.5x150mm
• 00811767024426: Stem Extension 10.5x100mm
• 00811767024419: Stem Extension 10.5x75mm
• 00811767024402: Stem Extension 9x150mm
• 00811767024396: Stem Extension 9x100mm
• 00811767024389: Stem Extension 9x75mm