Orbitum X Staple FO-1000-1208

GUDID B565FO100012080

12mm Round Staple

CPM MEDICAL CONSULTANTS, LLC

Orthopaedic bone staple, non-adjustable, non-sterile

• Primary Device ID: B565FO100012080
• NIH Device Record Key: 03867d08-44c7-48b9-8fb3-09c01f273f5c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Orbitum X Staple
• Version Model Number: Rev A
• Catalog Number: FO-1000-1208
• 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	B565FO100012080 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173693

FDA Product Code

• JDR: Staple, Fixation, Bone

Sterilization

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

[B565FO100012080]

Moist Heat or Steam Sterilization

[B565FO100012080]

Moist Heat or Steam Sterilization

[B565FO100012080]

Moist Heat or Steam Sterilization

[B565FO100012080]

Moist Heat or Steam Sterilization

[B565FO100012080]

Moist Heat or Steam Sterilization

[B565FO100012080]

Moist Heat or Steam Sterilization

[B565FO100012080]

Moist Heat or Steam Sterilization

[B565FO100012080]

Moist Heat or Steam Sterilization

[B565FO100012080]

Moist Heat or Steam Sterilization

[B565FO100012080]

Moist Heat or Steam Sterilization

[B565FO100012080]

Moist Heat or Steam Sterilization

[B565FO100012080]

Moist Heat or Steam Sterilization

[B565FO100012080]

Moist Heat or Steam Sterilization

[B565FO100012080]

Moist Heat or Steam Sterilization

[B565FO100012080]

Moist Heat or Steam Sterilization

[B565FO100012080]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-02-19
• Device Publish Date: 2021-02-11

On-Brand Devices [Orbitum X Staple]

• B565FO100020120: 20mm Round Staple
• B565FO100016100: 16mm Round Staple
• B565FO100012080: 12mm Round Staple
• B565FO100024160: 24mm VI Hourglass Staple
• B565FO100024140: 24mm Round Staple
• B565FO100124140: Orbitum X Round Staple Implant 24MM
• B565FO2021241: 24MM PLANER