FREEDOM PRIMARY PCK

GUDID 00811767025638

FEMORAL PRIMARY PCK E, RIGHT

MAXX ORTHOPEDICS, INC.

Uncoated knee femur prosthesis, metallic

• Primary Device ID: 00811767025638
• NIH Device Record Key: 3619ac49-9842-4254-ae0d-15bb94bae90c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FREEDOM PRIMARY PCK
• Version Model Number: LFPSRE00-ML
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00811767025638 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131481

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: 2017-02-28

On-Brand Devices [FREEDOM PRIMARY PCK]

• 00811767025713: FEMORAL PRIMARY PCK A, RIGHT
• 00811767025706: FEMORAL PRIMARY PCK A, LEFT
• 00811767025690: FEMORAL PRIMARY PCK H, RIGHT
• 00811767025683: FEMORAL PRIMARY PCK H, LEFT
• 00811767025676: FEMORAL PRIMARY PCK G, RIGHT
• 00811767025669: FEMORAL PRIMARY PCK G, LEFT
• 00811767025652: FEMORAL PRIMARY PCK F, RIGHT
• 00811767025645: FEMORAL PRIMARY PCK F, LEFT
• 00811767025638: FEMORAL PRIMARY PCK E, RIGHT
• 00811767025621: FEMORAL PRIMARY PCK E, LEFT
• 00811767025614: FEMORAL PRIMARY PCK D, RIGHT
• 00811767025607: FEMORAL PRIMARY PCK D, LEFT
• 00811767025591: FEMORAL PRIMARY PCK C, RIGHT
• 00811767025584: FEMORAL PRIMARY PCK C, LEFT
• 00811767025577: FEMORAL PRIMARY PCK B, RIGHT
• 00811767025560: FEMORAL PRIMARY PCK B, LEFT