Orbitum X Staple

GUDID B565FO100124140

Orbitum X Round Staple Implant 24MM

CPM MEDICAL CONSULTANTS, LLC

Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable

Primary Device ID	B565FO100124140
NIH Device Record Key	e943d521-fb70-4b48-9723-2eb5b366b5e6
Commercial Distribution Status	In Commercial Distribution
Brand Name	Orbitum X Staple
Version Model Number	FO-1001-2414
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
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
Phone	972-331-5860
Email	xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B565FO100124140 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K173693

FDA Product Code

JDR	Staple, Fixation, Bone