Orbitum Staple System FO-2020-16

GUDID B565FO2020161

16MM STAPLE DRILL W/ STOPS

CPM MEDICAL CONSULTANTS, LLC

Orthopaedic bone staple driver

• Primary Device ID: B565FO2020161
• NIH Device Record Key: e1b90674-d4bc-497c-9bd3-ae2c3141640d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Orbitum Staple System
• Version Model Number: REV A
• Catalog Number: FO-2020-16
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B565FO2020161 [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

[B565FO2020161]

Moist Heat or Steam Sterilization

[B565FO2020161]

Moist Heat or Steam Sterilization

[B565FO2020161]

Moist Heat or Steam Sterilization

[B565FO2020161]

Moist Heat or Steam Sterilization

[B565FO2020161]

Moist Heat or Steam Sterilization

[B565FO2020161]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-05-20
• Device Publish Date: 2022-05-12

On-Brand Devices [Orbitum Staple System]

• B565FO20150: Clinical Sizer
• B565FO20060: Drill Template
• B565FO2004200: 20mm Punch
• B565FO2004160: 16mm Punch
• B565FO2004120: 12mm Punch
• B565FO20030: Tamp
• B565FO2002200: 20mm Inserter
• B565FO2002160: 16mm Inserter
• B565FO2002120: 12mm Inserter
• B565FO20010: 1.5mm Drill
• B565FO20162060: 2.0 MM K-WIRE, 6 INCH LENGTH, TROCAR-TROCAR
• B565FO20161660: 1.6 MM K-WIRE, 6 INCH LENGTH, TROCAR-TROCAR
• B565FO20161160: 1.1 MM K-WIRE, 6 INCH LENGTH, TROCAR-TROCAR
• B565FO20160960: 0.90 MM K-WIRE, 6 INCH LENGTH, TROCAR-TROCAR
• B565FO20132060: 2.0 MM K-WIRE, 6 INCH LENGTH, TROCAR-BLUNT
• B565FO20131660: 1.6 MM K-WIRE, 6 INCH LENGTH, TROCAR-BLUNT
• B565FO20131160: 1.1 MM K-WIRE, 6 INCH LENGTH, TROCAR-BLUNT
• B565FO20130960: 0.90 MM K-WIRE, 6 INCH LENGTH, TROCAR-BLUNT
• B565FO20142091: 2.0 mm K-Wire, 9 Inch Length, Trocar-Blunt-Olive
• B565FO20142061: 2.0 mm K-Wire, 6 Inch Length, Trocar-Blunt-Olive
• B565FO20141661: 1.6 mm K-Wire, 6 Inch Length, Trocar-Blunt-Olive
• B565FO20141161: 1.1 mm K-Wire, 6 Inch Length, Trocar-Blunt-Olive
• B565FO20140961: 0.9 mm K-Wire, 6 Inch Length, Trocar-Blunt-Olive
• B565FO2007201: Punch VI 20mm
• B565FO2007161: Punch VI 16mm
• B565FO2007121: Punch VI 12mm
• B565FO2020201: 20MM STAPLE DRILL W/ STOPS
• B565FO2020161: 16MM STAPLE DRILL W/ STOPS
• B565FO2020121: 12mm STAPLE DRILL W/ STOPS
• B565FO20212001: 20MM Planer
• B565FO20211601: 16MM Planer
• B565FO20211201: 12MM Planer