Tibial Revision Platform M-1325-3603

GUDID B565M132536031

Femoral Head, Ceramic Sz 36 L

CPM MEDICAL CONSULTANTS, LLC

Ceramic-on-polyethylene total hip prosthesis Ceramic-on-polyethylene total hip prosthesis Ceramic-on-polyethylene total hip prosthesis Ceramic-on-polyethylene total hip prosthesis Ceramic-on-polyethylene total hip prosthesis Ceramic-on-polyethylene total hip prosthesis Ceramic-on-polyethylene total hip prosthesis Ceramic-on-polyethylene total hip prosthesis Ceramic-on-polyethylene total hip prosthesis Ceramic-on-polyethylene total hip prosthesis Ceramic-on-polyethylene total hip prosthesis Ceramic-on-polyethylene total hip prosthesis Ceramic-on-polyethylene total hip prosthesis Ceramic-on-polyethylene total hip prosthesis Ceramic-on-polyethylene total hip prosthesis Ceramic-on-polyethylene total hip prosthesis

• Primary Device ID: B565M132536031
• NIH Device Record Key: 0e8ebe21-cf81-4c6a-8be3-b755b26f2bcb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tibial Revision Platform
• Version Model Number: Rev A
• Catalog Number: M-1325-3603
• 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: true
• 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	B565M132536031 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143314

FDA Product Code

• LPH: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

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: 2022-02-23
• Device Publish Date: 2022-02-15

On-Brand Devices [Tibial Revision Platform]

• B565M32024615R0: Tibial Augment Size 6, 15mm Right
• B565M32024615L0: Tibial Augment Size 6, 15mm Left
• B565M32024610R0: Tibial Augment Size 6, 10mm Right
• B565M32024610L0: Tibial Augment Size 6, 10mm Left
• B565M32024605N0: Tibial Augment Size 6, 5mm Neutral
• B565M32024515R0: Tibial Augment Size 5, 15mm Right
• B565M32024515L0: Tibial Augment Size 5, 15mm Left
• B565M32024510R0: Tibial Augment Size 5, 10mm Right
• B565M32024510L0: Tibial Augment Size 5, 10mm Left
• B565M32024505N0: Tibial Augment Size 5, 5mm Neutral
• B565M32024415R0: Tibial Augment Size 4, 15mm Right
• B565M32024415L0: Tibial Augment Size 4, 15mm Left
• B565M32024410R0: Tibial Augment Size 4, 10mm Right
• B565M32024410L0: Tibial Augment Size 4, 10mm Left
• B565M32024405N0: Tibial Augment Size 4, 5mm Neutral
• B565M32024315R0: Tibial Augment Size 3, 15mm Right
• B565M32024315L0: Tibial Augment Size 3, 15mm Left
• B565M32024310R0: Tibial Augment Size 3, 10mm Right
• B565M32024310L0: Tibial Augment Size 3, 10mm Left
• B565M32024305N0: Tibial Augment Size 3, 5mm Neutral
• B565M32024215R0: Tibial Augment Size 2, 15mm Right
• B565M32024215L0: Tibial Augment Size 2, 15mm Left
• B565M32024210R0: Tibial Augment Size 2, 10mm Right
• B565M32024210L0: Tibial Augment Size 2, 10mm Left
• B565M32024205N0: Tibial Augment Size 2, 5mm Neutral
• B565M32024115R0: Tibial Augment Size 1, 15mm Right
• B565M32024115L0: Tibial Augment Size 1, 15mm Left
• B565M32024110R0: Tibial Augment Size 1, 10mm Right
• B565M32024110L0: Tibial Augment Size 1, 10mm Left
• B565M32024105N0: Tibial Augment Size 1, 5mm Neutral
• B565M32024015R0: Tibial Augment Size 0, 15mm Right
• B565M32024015L0: Tibial Augment Size 0, 15mm Left
• B565M32024010R0: Tibial Augment Size 0, 10mm Right
• B565M32024010L0: Tibial Augment Size 0, 10mm Left
• B565M32024005N0: Tibial Augment Size 0, 5mm Neutral
• B565M320230060: Stem Offset Adapter 6mm
• B565M320230040: Stem Offset Adapter 4mm
• B565M320230020: Stem Offset Adapter 2mm
• B565M320220750: Stem 20mm x 75mm - Press-Fit
• B565M320220150: Stem 20mm x 150mm - Press-Fit
• B565M320220100: Stem 20mm x 100mm - Press-Fit
• B565M320218750: Stem 18mm x 75mm - Press-Fit
• B565M320218150: Stem 18mm x 150mm - Press-Fit
• B565M320218100: Stem 18mm x 100mm - Press-Fit
• B565M320216750: Stem 16mm x 75mm - Press-Fit
• B565M320216150: Stem 16mm x 150mm - Press-Fit
• B565M320216100: Stem 16mm x 100mm - Press-Fit
• B565M320214750: Stem 14mm x 75mm - Press-Fit
• B565M320214300: Stem 14mm x 30mm - Cemented
• B565M320214150: Stem 14mm x 150mm - Press-Fit