FREEDOM PARTIAL KNEE

GUDID 00811767025553

PARTIAL ALL POLY TIBIAL, LARGE

MAXX ORTHOPEDICS, INC.

Unicondylar knee prosthesis Unicondylar knee prosthesis

• Primary Device ID: 00811767025553
• NIH Device Record Key: b633ffdc-67e7-4d4a-b118-10100c0c967e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FREEDOM PARTIAL KNEE
• Version Model Number: 311408
• 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

• Height: 8.5 Millimeter
• Height: 8.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811767025553 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072704

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: 2016-02-29

On-Brand Devices [FREEDOM PARTIAL KNEE]

• 00811767025553: PARTIAL ALL POLY TIBIAL, LARGE
• 00811767025546: PARTIAL ALL POLY TIBIAL, MEDIUM
• 00811767025539: PARTIAL ALL POLY TIBIAL, SMALL
• 00811767025461: PARTIAL ALL POLY TIBIAL, LARGE, RIGHT MEDIAL
• 00811767025454: PARTIAL ALL POLY TIBIAL, LARGE, RIGHT MEDIAL
• 00811767025447: PARTIAL ALL POLY TIBIAL, MEDIUM, RIGHT MEDIAL
• 00811767025430: PARTIAL ALL POLY TIBIAL, MEDIUM, RIGHT MEDIAL
• 00811767025423: PARTIAL ALL POLY TIBIAL, SMALL, RIGHT MEDIAL
• 00811767025416: PARTIAL ALL POLY TIBIAL, SMALL, RIGHT MEDIAL
• 00811767025409: PARTIAL ALL POLY TIBIAL, LARGE
• 00811767025393: PARTIAL ALL POLY TIBIAL, LARGE
• 00811767025386: PARTIAL ALL POLY TIBIAL, MEDIUM
• 00811767025379: PARTIAL ALL POLY TIBIAL, MEDIUM
• 00811767025362: PARTIAL ALL POLY TIBIAL, SMALL
• 00811767025355: PARTIAL ALL POLY TIBIAL, SMALL
• 00811767025348: PARTIAL FEMORAL w/ PARTIAL POST, LARGE, RIGHT MEDIAL
• 00811767025331: PARTIAL FEMORAL w/ PARTIAL POST, MEDIUM, RIGHT MEDIAL
• 00811767025324: PARTIAL FEMORAL w/ PARTIAL POST, SMALL, RIGHT MEDIAL
• 00811767025317: PARTIAL FEMORAL w/ PARTIAL POST, LARGE, LEFT MEDIAL
• 00811767025300: PARTIAL FEMORAL w/ PARTIAL POST, MEDIUM, LEFT MEDIAL
• 00811767025294: PARTIAL FEMORAL w/ PARTIAL POST, SMALL, LEFT MEDIAL
• 00811767025287: PARTIAL FEMORAL w/ FULL POST, LARGE, RIGHT MEDIAL
• 00811767025270: PARTIAL FEMORAL w/ FULL POST, MEDIUM, RIGHT MEDIAL
• 00811767025263: PARTIAL FEMORAL w/ FULL POST, SMALL, RIGHT MEDIAL
• 00811767025256: PARTIAL FEMORAL w/ FULL POST, LARGE, LEFT MEDIAL
• 00811767025249: PARTIAL FEMORAL w/ FULL POST, MEDIUM, LEFT MEDIAL
• 00811767025232: PARTIAL FEMORAL w/ FULL POST, SMALL, LEFT MEDIAL