STERIZO Total Hip System M-1200-0046-01

GUDID B565M12000046011

Apical Hole Plug

CPM MEDICAL CONSULTANTS, LLC

Coated femoral stem prosthesis, modular

• Primary Device ID: B565M12000046011
• NIH Device Record Key: df7dc3bb-0626-46de-8da3-06ce15616d23
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STERIZO Total Hip System
• Version Model Number: Rev A
• Catalog Number: M-1200-0046-01
• 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	B565M12000046011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151424

FDA Product Code

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

Sterilization

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

[B565M12000046011]

Moist Heat or Steam Sterilization

[B565M12000046011]

Moist Heat or Steam Sterilization

[B565M12000046011]

Moist Heat or Steam Sterilization

[B565M12000046011]

Moist Heat or Steam Sterilization

[B565M12000046011]

Moist Heat or Steam Sterilization

[B565M12000046011]

Moist Heat or Steam Sterilization

[B565M12000046011]

Moist Heat or Steam Sterilization

[B565M12000046011]

Moist Heat or Steam Sterilization

[B565M12000046011]

Moist Heat or Steam Sterilization

[B565M12000046011]

Moist Heat or Steam Sterilization

[B565M12000046011]

Moist Heat or Steam Sterilization

[B565M12000046011]

Moist Heat or Steam Sterilization

[B565M12000046011]

Moist Heat or Steam Sterilization

[B565M12000046011]

Moist Heat or Steam Sterilization

[B565M12000046011]

Moist Heat or Steam Sterilization

[B565M12000046011]

Moist Heat or Steam Sterilization

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 [STERIZO Total Hip System]

• B565M110013751: Taper Stem, Std Offset Sz 13.75
• B565M110012501: Taper Stem, Std Offset Sz 12.5
• B565M110011251: Taper Stem, Std Offset Sz 11.25
• B565M110010001: Taper Stem, Std Offset Sz 10.0
• B565M110008751: Taper Stem, Std Offset Sz 8.75
• B565M110007501: Taper Stem, Std Offset Sz 7.5
• B565M110006001: Taper Stem, Std Offset Sz 6.0
• B565M221550321: Liner, Elevated Face Sz 50x32
• B565M150040011: Dome Impactor Sz 40
• B565M150036011: Dome Impactor Sz 36
• B565M150032011: Dome Impactor Sz 32
• B565M150028011: Dome Impactor Sz 28
• B565M150010181: Bi-Polar Trial Handle
• B565M150010171: Calcar Planar
• B565M150010161: Cup Alignment Guide
• B565M150010151: Shell Impactor Spacer
• B565M150010141: Handle, Straight Reamer
• B565M110017751: Taper Stem, Std Offset Sz 17.75
• B565M110015001: Taper Stem, Std Offset Sz 15.0
• B565M221552321: Liner, Elevated Face Sz 52x32
• B565MEBS65451: Bone Screw, 6.5mm X 45mm
• B565MEBS65401: Bone Screw, 6.5mm X 40mm
• B565MEBS65351: Bone Screw, 6.5mm X 35mm
• B565MEBS65301: Bone Screw, 6.5mm X 30mm
• B565MEBS65251: Bone Screw, 6.5mm X 25mm
• B565MEBS65201: Bone Screw, 6.5mm X 20mm
• B565MEBS65151: Bone Screw, 6.5mm X 15mm
• B565M221566401: Liner, Elevated Face Sz 66x40
• B565M221566321: Liner, Elevated Face Sz 66x32
• B565M221566281: Liner, Elevated Face Sz 66x28
• B565M221562401: Liner, Elevated Face Sz 62x40
• B565M221562321: Liner, Elevated Face Sz 62x32
• B565M221562281: Liner, Elevated Face Sz 62x28
• B565M221558401: Liner, Elevated Face Sz 58x40
• B565M221558321: Liner, Elevated Face Sz 58x32
• B565M221558281: Liner, Elevated Face Sz 58x28
• B565M221554361: Liner, Elevated Face Sz 54x36
• B565M221554321: Liner, Elevated Face Sz 54x32
• B565M221554281: Liner, Elevated Face Sz 54x28
• B565M221552361: Liner, Elevated Face Sz 52x36
• B565M221552281: Liner, Elevated Face Sz 52x28
• B565M221550281: Liner, Elevated Face Sz 50x28
• B565M221546281: Liner, Elevated Face Sz 46x28
• B565M220066401: Liner, Neutral Face Sz 66x40
• B565M220066321: Liner, Neutral Face Sz 66x32
• B565M220066281: Liner, Neutral Face Sz 66x28
• B565M220062401: Liner, Neutral Face Sz 62x40
• B565M220062321: Liner, Neutral Face Sz 62x32
• B565M220062281: Liner, Neutral Face Sz 62x28
• B565M220058401: Liner, Neutral Face Sz 58x40