TIBIAL REVISON PLATFORM M-3212-4205-R

GUDID B565M32124205R1

TIBIAL AUGMENT TRIAL SZ 2 5MM RIGHT

CPM MEDICAL CONSULTANTS, LLC

Posterior-stabilized total knee prosthesis Posterior-stabilized total knee prosthesis Posterior-stabilized total knee prosthesis Posterior-stabilized total knee prosthesis Posterior-stabilized total knee prosthesis Posterior-stabilized total knee prosthesis Posterior-stabilized total knee prosthesis Posterior-stabilized total knee prosthesis Posterior-stabilized total knee prosthesis Posterior-stabilized total knee prosthesis Posterior-stabilized total knee prosthesis Posterior-stabilized total knee prosthesis Posterior-stabilized total knee prosthesis Posterior-stabilized total knee prosthesis Posterior-stabilized total knee prosthesis Posterior-stabilized total knee prosthesis

• Primary Device ID: B565M32124205R1
• NIH Device Record Key: a54368c8-d075-4ac9-94c8-5428c84d8b67
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TIBIAL REVISON PLATFORM
• Version Model Number: REV C
• Catalog Number: M-3212-4205-R
• Company DUNS: 017138000
• Company Name: CPM MEDICAL CONSULTANTS, LLC
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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: 972-331-5860
• Email: xx@xx.xx
• Phone: 972-331-5860
• Email: xx@xx.xx
• Phone: 972-331-5860
• Email: xx@xx.xx
• Phone: 972-331-5860
• Email: xx@xx.xx
• Phone: 972-331-5860
• Email: xx@xx.xx
• Phone: 972-331-5860
• Email: xx@xx.xx
• Phone: 972-331-5860
• Email: xx@xx.xx
• Phone: 972-331-5860
• Email: xx@xx.xx
• Phone: 972-331-5860
• Email: xx@xx.xx
• Phone: 972-331-5860
• Email: xx@xx.xx
• Phone: 972-331-5860
• Email: xx@xx.xx
• Phone: 972-331-5860
• Email: xx@xx.xx
• Phone: 972-331-5860
• Email: xx@xx.xx
• Phone: 972-331-5860
• Email: xx@xx.xx
• Phone: 972-331-5860
• Email: xx@xx.xx
• Phone: 972-331-5860
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B565M32124205R1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210695

FDA Product Code

• JWH: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[B565M32124205R1]

Moist Heat or Steam Sterilization

[B565M32124205R1]

Moist Heat or Steam Sterilization

[B565M32124205R1]

Moist Heat or Steam Sterilization

[B565M32124205R1]

Moist Heat or Steam Sterilization

[B565M32124205R1]

Moist Heat or Steam Sterilization

[B565M32124205R1]

Moist Heat or Steam Sterilization

[B565M32124205R1]

Moist Heat or Steam Sterilization

[B565M32124205R1]

Moist Heat or Steam Sterilization

[B565M32124205R1]

Moist Heat or Steam Sterilization

[B565M32124205R1]

Moist Heat or Steam Sterilization

[B565M32124205R1]

Moist Heat or Steam Sterilization

[B565M32124205R1]

Moist Heat or Steam Sterilization

[B565M32124205R1]

Moist Heat or Steam Sterilization

[B565M32124205R1]

Moist Heat or Steam Sterilization

[B565M32124205R1]

Moist Heat or Steam Sterilization

[B565M32124205R1]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-04-04
• Device Publish Date: 2022-03-25

On-Brand Devices [TIBIAL REVISON PLATFORM]

• B565M32124605R1: TIBIAL AUGMENT TRIAL SZ 6 5MM RIGHT
• B565M32124605L1: TIBIAL AUGMENT TRIAL SZ 6 5MM LEFT
• B565M32124510R1: TIBIAL AUGMENT TRIAL SZ 5 10MM RIGHT
• B565M32124505R1: TIBIAL AUGMENT TRIAL SZ 5 5MM RIGHT
• B565M32124505L1: TIBIAL AUGMENT TRIAL SZ 5 5MM LEFT
• B565M32124405R1: TIBIAL AUGMENT TRIAL SZ 4 5MM RIGHT
• B565M32124405L1: TIBIAL AUGMENT TRIAL SZ 4 5MM LEFT
• B565M32124305R1: TIBIAL AUGMENT TRIAL SZ 3 5MM RIGHT
• B565M32124305L1: TIBIAL AUGMENT TRIAL SZ 3 5MM LEFT
• B565M32124205R1: TIBIAL AUGMENT TRIAL SZ 2 5MM RIGHT
• B565M32124205L1: TIBIAL AUGMENT TRIAL SZ 2 5MM LEFT
• B565M32124105R1: TIBIAL AUGMENT TRIAL SZ 1 5MM RIGHT
• B565M32124105L1: TIBIAL AUGMENT TRIAL SZ 1 5MM LEFT
• B565M32124005R1: TIBIAL AUGMENT TRIAL SZ 0 5MM RIGHT
• B565M32124005L1: TIBIAL AUGMENT TRIAL SZ 0 5MM LEFT