Freedom Primary PCK

GUDID 00811767027168

FREEDOM TIBIAL LINER SIZE B1-2, PRIMARY PCK

MAXX ORTHOPEDICS, INC.

Uncoated knee femur prosthesis, metallic

• Primary Device ID: 00811767027168
• NIH Device Record Key: f45682b8-890f-416b-8540-4f84946a5028
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Freedom Primary PCK
• Version Model Number: LLPSXB113-ML
• Company DUNS: 792030103
• Company Name: MAXX ORTHOPEDICS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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

Customer Support Contacts

• Phone: (484) 342-0096
• Email: don.guthner@maxxortho.com
• Phone: (484) 342-0096
• Email: don.guthner@maxxortho.com
• Phone: (484) 342-0096
• Email: don.guthner@maxxortho.com
• Phone: (484) 342-0096
• Email: don.guthner@maxxortho.com
• Phone: (484) 342-0096
• Email: don.guthner@maxxortho.com
• Phone: (484) 342-0096
• Email: don.guthner@maxxortho.com
• Phone: (484) 342-0096
• Email: don.guthner@maxxortho.com
• Phone: (484) 342-0096
• Email: don.guthner@maxxortho.com
• Phone: (484) 342-0096
• Email: don.guthner@maxxortho.com
• Phone: (484) 342-0096
• Email: don.guthner@maxxortho.com
• Phone: (484) 342-0096
• Email: don.guthner@maxxortho.com
• Phone: (484) 342-0096
• Email: don.guthner@maxxortho.com
• Phone: (484) 342-0096
• Email: don.guthner@maxxortho.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811767027168 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-07-29
• Device Publish Date: 2025-07-21

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
• 00811767027311: FREEDOM TIBIAL LINER SIZE C3-4, PRIMARY PCK
• 00811767027281: FREEDOM TIBIAL LINER SIZE C1-2, PRIMARY PCK
• 00811767027274: FREEDOM TIBIAL LINER SIZE C1-2, PRIMARY PCK
• 00811767027250: FREEDOM TIBIAL LINER SIZE C1-2, PRIMARY PCK
• 00811767027243: FREEDOM TIBIAL LINER SIZE C1-2, PRIMARY PCK
• 00811767027229: FREEDOM TIBIAL LINER SIZE C1-2, PRIMARY PCK
• 00811767027199: FREEDOM TIBIAL LINER SIZE B1-2, PRIMARY PCK
• 00811767027182: FREEDOM TIBIAL LINER SIZE B1-2, PRIMARY PCK
• 00811767027168: FREEDOM TIBIAL LINER SIZE B1-2, PRIMARY PCK
• 00811767027151: FREEDOM TIBIAL LINER SIZE B1-2, PRIMARY PCK
• 00811767027137: FREEDOM TIBIAL LINER SIZE B1-2, PRIMARY PCK
• 00811767029599: FREEDOM TIBIAL LINER SIZE G7-8, PRIMARY PCK
• 00811767029575: FREEDOM TIBIAL LINER SIZE H7-8, PRIMARY PCK
• 00811767029568: FREEDOM TIBIAL LINER SIZE H7-8, PRIMARY PCK
• 00811767029544: FREEDOM TIBIAL LINER SIZE H7-8, PRIMARY PCK
• 00811767029537: FREEDOM TIBIAL LINER SIZE H7-8, PRIMARY PCK
• 00811767029513: FREEDOM TIBIAL LINER SIZE H7-8, PRIMARY PCK
• 00811767029483: FREEDOM TIBIAL LINER SIZE G7-8, PRIMARY PCK
• 00811767029476: FREEDOM TIBIAL LINER SIZE G7-8, PRIMARY PCK
• 00811767029452: FREEDOM TIBIAL LINER SIZE G7-8, PRIMARY PCK
• 00811767029445: FREEDOM TIBIAL LINER SIZE G7-8, PRIMARY PCK
• 00811767029407: FREEDOM TIBIAL LINER SIZE G5-6, PRIMARY PCK
• 00811767029391: FREEDOM TIBIAL LINER SIZE G5-6, PRIMARY PCK
• 00811767029377: FREEDOM TIBIAL LINER SIZE G5-6, PRIMARY PCK
• 00811767029360: FREEDOM TIBIAL LINER SIZE G5-6, PRIMARY PCK
• 00811767029346: FREEDOM TIBIAL LINER SIZE G5-6, PRIMARY PCK
• 00811767029315: FREEDOM TIBIAL LINER SIZE F7-8, PRIMARY PCK
• 00811767029308: FREEDOM TIBIAL LINER SIZE F7-8, PRIMARY PCK
• 00811767029285: FREEDOM TIBIAL LINER SIZE F7-8, PRIMARY PCK
• 00811767029278: FREEDOM TIBIAL LINER SIZE F7-8, PRIMARY PCK
• 00811767029254: FREEDOM TIBIAL LINER SIZE F7-8, PRIMARY PCK
• 00811767029223: FREEDOM TIBIAL LINER SIZE F5-6, PRIMARY PCK
• 00811767027724: FREEDOM TIBIAL LINER SIZE F5-6, PRIMARY PCK
• 00811767027700: FREEDOM TIBIAL LINER SIZE F5-6, PRIMARY PCK