Orbitum X Staple

GUDID B565FO2021241

24MM PLANER

CPM MEDICAL CONSULTANTS, LLC

Orthopaedic surgical procedure kit, non-medicated, reusable

• Primary Device ID: B565FO2021241
• NIH Device Record Key: 30ae92a6-b298-426a-a9a6-7dfa3f03b446
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Orbitum X Staple
• Version Model Number: FO-2021-24
• 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
• Phone: 972-331-5860
• Email: xx@xx.xx
• Phone: 972-331-5860
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B565FO2021241 [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

[B565FO2021241]

Moist Heat or Steam Sterilization

[B565FO2021241]

Moist Heat or Steam Sterilization

[B565FO2021241]

Moist Heat or Steam Sterilization

[B565FO2021241]

Moist Heat or Steam Sterilization

[B565FO2021241]

Moist Heat or Steam Sterilization

[B565FO2021241]

Moist Heat or Steam Sterilization

[B565FO2021241]

Moist Heat or Steam Sterilization

[B565FO2021241]

Moist Heat or Steam Sterilization

[B565FO2021241]

Moist Heat or Steam Sterilization

[B565FO2021241]

Moist Heat or Steam Sterilization

[B565FO2021241]

Moist Heat or Steam Sterilization

[B565FO2021241]

Moist Heat or Steam Sterilization

[B565FO2021241]

Moist Heat or Steam Sterilization

[B565FO2021241]

Moist Heat or Steam Sterilization

[B565FO2021241]

Moist Heat or Steam Sterilization

[B565FO2021241]

Moist Heat or Steam Sterilization

[B565FO2021241]

Moist Heat or Steam Sterilization

[B565FO2021241]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-12-19
• Device Publish Date: 2023-12-11

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