Dark Star Deformity DSD3-7590

GUDID B07510113975900

Triple Lead Fine Pedicle Screw - Ø7.5mm x 90mm

Republic Spine, 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

Primary Device ID	B07510113975900
NIH Device Record Key	4265f900-9e71-4baa-a97e-de454fe79c6a
Commercial Distribution Status	In Commercial Distribution
Brand Name	Dark Star Deformity
Version Model Number	101139-7590
Catalog Number	DSD3-7590
Company DUNS	061891717
Company Name	Republic Spine, LLC
Device Count	1
DM Exempt	true
Pre-market Exempt	false
MRI Safety Status	MR Unsafe
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	false
OTC Over-The-Counter	false

Customer Support Contacts

Phone	561-334-2421
Email	james@rspine.com
Phone	561-334-2421
Email	james@rspine.com
Phone	561-334-2421
Email	james@rspine.com
Phone	561-334-2421
Email	james@rspine.com
Phone	561-334-2421
Email	james@rspine.com
Phone	561-334-2421
Email	james@rspine.com
Phone	561-334-2421
Email	james@rspine.com
Phone	561-334-2421
Email	james@rspine.com
Phone	561-334-2421
Email	james@rspine.com
Phone	561-334-2421
Email	james@rspine.com
Phone	561-334-2421
Email	james@rspine.com
Phone	561-334-2421
Email	james@rspine.com
Phone	561-334-2421
Email	james@rspine.com
Phone	561-334-2421
Email	james@rspine.com

Device Dimensions

Length	90 Millimeter
Outer Diameter	7.5 Millimeter
Length	90 Millimeter
Outer Diameter	7.5 Millimeter
Length	90 Millimeter
Outer Diameter	7.5 Millimeter
Length	90 Millimeter
Outer Diameter	7.5 Millimeter
Length	90 Millimeter
Outer Diameter	7.5 Millimeter
Length	90 Millimeter
Outer Diameter	7.5 Millimeter
Length	90 Millimeter
Outer Diameter	7.5 Millimeter
Length	90 Millimeter
Outer Diameter	7.5 Millimeter
Length	90 Millimeter
Outer Diameter	7.5 Millimeter
Length	90 Millimeter
Outer Diameter	7.5 Millimeter
Length	90 Millimeter
Outer Diameter	7.5 Millimeter
Length	90 Millimeter
Outer Diameter	7.5 Millimeter
Length	90 Millimeter
Outer Diameter	7.5 Millimeter
Length	90 Millimeter
Outer Diameter	7.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B07510113975900 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K223096

FDA Product Code

NKB	Thoracolumbosacral Pedicle Screw System