Black Dimaond POCT 2420-1150

GUDID B06224201150

3.5x150mm Rod, Straight, Black Diamond POCT

Osseus Fusion Systems, LLC

Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile

Primary Device ID	B06224201150
NIH Device Record Key	18ecf329-47ac-43d3-a4b7-c220ec263407
Commercial Distribution Status	In Commercial Distribution
Brand Name	Black Dimaond POCT
Version Model Number	2420-1150
Catalog Number	2420-1150
Company DUNS	933442068
Company Name	Osseus Fusion Systems, 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B06224201150 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K222107

FDA Product Code

NKG	Posterior Cervical Screw System