AACA05045

GUDID 00841379113386

MONOAXIAL SCREW

HYHTE HOLDINGS, INC.

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 Bone-screw internal spinal fixation system, non-sterile

Primary Device ID	00841379113386
NIH Device Record Key	664b74ab-cec5-473f-9311-79614a8a7614
Commercial Distribution Status	In Commercial Distribution
Version Model Number	AACA05045
Catalog Number	AACA05045
Company DUNS	073029645
Company Name	HYHTE HOLDINGS, INC.
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	7608148047
Email	PARKER@ASTURAMEDICAL.COM
Phone	7608148047
Email	PARKER@ASTURAMEDICAL.COM
Phone	7608148047
Email	PARKER@ASTURAMEDICAL.COM
Phone	7608148047
Email	PARKER@ASTURAMEDICAL.COM
Phone	7608148047
Email	PARKER@ASTURAMEDICAL.COM
Phone	7608148047
Email	PARKER@ASTURAMEDICAL.COM
Phone	7608148047
Email	PARKER@ASTURAMEDICAL.COM
Phone	7608148047
Email	PARKER@ASTURAMEDICAL.COM
Phone	7608148047
Email	PARKER@ASTURAMEDICAL.COM
Phone	7608148047
Email	PARKER@ASTURAMEDICAL.COM
Phone	7608148047
Email	PARKER@ASTURAMEDICAL.COM
Phone	7608148047
Email	PARKER@ASTURAMEDICAL.COM
Phone	7608148047
Email	PARKER@ASTURAMEDICAL.COM
Phone	7608148047
Email	PARKER@ASTURAMEDICAL.COM
Phone	7608148047
Email	PARKER@ASTURAMEDICAL.COM
Phone	7608148047
Email	PARKER@ASTURAMEDICAL.COM
Phone	7608148047
Email	PARKER@ASTURAMEDICAL.COM

Device Dimensions

Length	45 Millimeter
Outer Diameter	10.5 Millimeter
Length	45 Millimeter
Outer Diameter	10.5 Millimeter
Length	45 Millimeter
Outer Diameter	10.5 Millimeter
Length	45 Millimeter
Outer Diameter	10.5 Millimeter
Length	45 Millimeter
Outer Diameter	10.5 Millimeter
Length	45 Millimeter
Outer Diameter	10.5 Millimeter
Length	45 Millimeter
Outer Diameter	10.5 Millimeter
Length	45 Millimeter
Outer Diameter	10.5 Millimeter
Length	45 Millimeter
Outer Diameter	10.5 Millimeter
Length	45 Millimeter
Outer Diameter	10.5 Millimeter
Length	45 Millimeter
Outer Diameter	10.5 Millimeter
Length	45 Millimeter
Outer Diameter	10.5 Millimeter
Length	45 Millimeter
Outer Diameter	10.5 Millimeter
Length	45 Millimeter
Outer Diameter	10.5 Millimeter
Length	45 Millimeter
Outer Diameter	10.5 Millimeter
Length	45 Millimeter
Outer Diameter	10.5 Millimeter
Length	45 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841379113386 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K153446

FDA Product Code

OSH	Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis