FREEDOM PCK

GUDID 00811767024297

Stemmed Tibial Base Plate Size 6

MAXX ORTHOPEDICS, INC.

Uncoated knee tibia prosthesis, metallic Uncoated knee tibia prosthesis, metallic

• Primary Device ID: 00811767024297
• NIH Device Record Key: c9e10832-c60e-46e3-9703-053ef75c736d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FREEDOM PCK
• Version Model Number: RTUUX600-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: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter
• Length: 50 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811767024297 [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: 4
• Public Version Date: 2019-12-11
• Device Publish Date: 2015-10-01

On-Brand Devices [FREEDOM PCK]

• 00811767024310: Stemmed Tibial Base Plate Size 8
• 00811767024303: Stemmed Tibial Base Plate Size 7
• 00811767024297: Stemmed Tibial Base Plate Size 6
• 00811767024280: Stemmed Tibial Base Plate Size 5
• 00811767024273: Stemmed Tibial Base Plate Size 4
• 00811767024266: Stemmed Tibial Base Plate Size 3
• 00811767024259: Stemmed Tibial Base Plate Size 2
• 00811767024242: Stemmed Tibial Base Plate Size 1
• 00811767024235: Tibial Liner PCK, Size H7-8
• 00811767024228: Tibial Liner PCK, Size H7-8
• 00811767024211: Tibial Liner PCK, Size H7-8
• 00811767024204: Tibial Liner PCK, Size H7-8
• 00811767024198: Tibial Liner PCK, Size H7-8
• 00811767024181: Tibial Liner PCK, Size H7-8
• 00811767024174: Tibial Liner PCK, Size H7-8
• 00811767024167: Tibial Liner PCK, Size G7-8
• 00811767024150: Tibial Liner PCK, Size G7-8
• 00811767024143: Tibial Liner PCK, Size G7-8
• 00811767024136: Tibial Liner PCK, Size G7-8
• 00811767024129: Tibial Liner PCK, Size G7-8
• 00811767024112: Tibial Liner PCK, Size G7-8
• 00811767024105: Tibial Liner PCK, Size G7-8
• 00811767024099: Tibial Liner PCK, Size G5-6
• 00811767024082: Tibial Liner PCK, Size G5-6
• 00811767024075: Tibial Liner PCK, Size G5-6
• 00811767024068: Tibial Liner PCK, Size G5-6
• 00811767024051: Tibial Liner PCK, Size G5-6
• 00811767024044: Tibial Liner PCK, Size G5-6
• 00811767024037: Tibial Liner PCK, Size G5-6
• 00811767024020: Tibial Liner PCK, Size F7-8
• 00811767024013: Tibial Liner PCK, Size F7-8
• 00811767024006: Tibial Liner PCK, Size F7-8
• 00811767023993: Tibial Liner PCK, Size F7-8
• 00811767023986: Tibial Liner PCK, Size F7-8
• 00811767023979: Tibial Liner PCK, Size F7-8
• 00811767023962: Tibial Liner PCK, Size F7-8
• 00811767023955: Tibial Liner PCK, Size F5-6
• 00811767023948: Tibial Liner PCK, Size F5-6
• 00811767023931: Tibial Liner PCK, Size F5-6
• 00811767023924: Tibial Liner PCK, Size F5-6
• 00811767023917: Tibial Liner PCK, Size F5-6
• 00811767023900: Tibial Liner PCK, Size F5-6
• 00811767023894: Tibial Liner PCK, Size F5-6
• 00811767023887: Tibial Liner PCK, Size F3-4
• 00811767023870: Tibial Liner PCK, Size F3-4
• 00811767023863: Tibial Liner PCK, Size F3-4
• 00811767023856: Tibial Liner PCK, Size F3-4
• 00811767023849: Tibial Liner PCK, Size F3-4
• 00811767023832: Tibial Liner PCK, Size F3-4
• 00811767023825: Tibial Liner PCK, Size F3-4