FREEDOM KNEE

GUDID 00811767021753

TIBIAL LINER CR G7-8 METALBACKED

MAXX ORTHOPEDICS, INC.

Uncoated knee tibia prosthesis, polyethylene

• Primary Device ID: 00811767021753
• NIH Device Record Key: e28c304e-85bf-425c-8328-8d0c12f8c698
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FREEDOM KNEE
• Version Model Number: MLCRXG717-K
• 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

• Depth: 17 Millimeter
• Depth: 17 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811767021753 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090411

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: 2015-09-30

On-Brand Devices [FREEDOM KNEE]

• 00811767023252: All Poly Tibial Liner CR, Size H7
• 00811767023245: All Poly Tibial Liner CR, Size H7
• 00811767023238: All Poly Tibial Liner CR, Size H7
• 00811767023221: All Poly Tibial Liner CR, Size H7
• 00811767023214: All Poly Tibial Liner CR, Size H7
• 00811767023207: All Poly Tibial Liner CR, Size G7
• 00811767023191: All Poly Tibial Liner CR, Size G7
• 00811767023184: All Poly Tibial Liner CR, Size G7
• 00811767023177: All Poly Tibial Liner CR, Size G7
• 00811767023160: All Poly Tibial Liner CR, Size G7
• 00811767023153: All Poly Tibial Liner CR, Size F5
• 00811767023146: All Poly Tibial Liner CR, Size F5
• 00811767023139: All Poly Tibial Liner CR, Size F5
• 00811767023122: All Poly Tibial Liner CR, Size F5
• 00811767023115: All Poly Tibial Liner CR, Size F5
• 00811767023108: All Poly Tibial Liner CR, Size E5
• 00811767023092: All Poly Tibial Liner CR, Size E5
• 00811767023085: All Poly Tibial Liner CR, Size E5
• 00811767023078: All Poly Tibial Liner CR, Size E5
• 00811767023061: All Poly Tibial Liner CR, Size E5
• 00811767023054: All Poly Tibial Liner CR, Size E4
• 00811767023047: All Poly Tibial Liner CR, Size E4
• 00811767023030: All Poly Tibial Liner CR, Size E4
• 00811767023023: All Poly Tibial Liner CR, Size E4
• 00811767023016: TIBIAL LINER, CR, E4, ALL-POLY
• 00811767023009: All Poly Tibial Liner CR, Size D4
• 00811767022996: All Poly Tibial Liner CR, Size D4
• 00811767022989: All Poly Tibial Liner CR, Size D4
• 00811767022972: All Poly Tibial Liner CR, Size D4
• 00811767022965: All Poly Tibial Liner CR, Size D4
• 00811767022958: All Poly Tibial Liner CR, Size D3
• 00811767022941: All Poly Tibial Liner CR, Size D3
• 00811767022934: All Poly Tibial Liner CR, Size D3
• 00811767022927: All Poly Tibial Liner CR, Size D3
• 00811767022910: All Poly Tibial Liner CR, Size D3
• 00811767022903: All Poly Tibial Liner CR, Size D2
• 00811767022897: All Poly Tibial Liner CR, Size D2
• 00811767022880: All Poly Tibial Liner CR, Size D2
• 00811767022873: All Poly Tibial Liner CR, Size D2
• 00811767022866: All Poly Tibial Liner CR, Size D2
• 00811767022859: All Poly Tibial Liner CR, Size C3
• 00811767022842: All Poly Tibial Liner CR, Size C3
• 00811767022835: All Poly Tibial Liner CR, Size C3
• 00811767022828: All Poly Tibial Liner CR, Size C3
• 00811767022811: All Poly Tibial Liner CR, Size C3
• 00811767022804: All Poly Tibial Liner CR, Size C2
• 00811767022798: All Poly Tibial Liner CR, Size C2
• 00811767022781: All Poly Tibial Liner CR, Size C2
• 00811767022774: All Poly Tibial Liner CR, Size C2
• 00811767022767: All Poly Tibial Liner CR, Size C2