FAJA50048

GUDID 00841379144557

POLYAXIAL SCREW #2

HYHTE HOLDINGS, INC.

Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable

Primary Device ID	00841379144557
NIH Device Record Key	3a7d4bca-507a-4ad5-8135-0d4221d1e67f
Commercial Distribution Status	In Commercial Distribution
Version Model Number	FAJA50048
Catalog Number	FAJA50048
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
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
Phone	7608148047
Email	PARKER@ASTURAMEDICAL.COM
Phone	7608148047
Email	PARKER@ASTURAMEDICAL.COM

Device Dimensions

Length	48 Millimeter
Width	5 Millimeter
Length	48 Millimeter
Width	5 Millimeter
Length	48 Millimeter
Width	5 Millimeter
Length	48 Millimeter
Width	5 Millimeter
Length	48 Millimeter
Width	5 Millimeter
Length	48 Millimeter
Width	5 Millimeter
Length	48 Millimeter
Width	5 Millimeter
Length	48 Millimeter
Width	5 Millimeter
Length	48 Millimeter
Width	5 Millimeter
Length	48 Millimeter
Width	5 Millimeter
Length	48 Millimeter
Width	5 Millimeter
Length	48 Millimeter
Width	5 Millimeter
Length	48 Millimeter
Width	5 Millimeter
Length	48 Millimeter
Width	5 Millimeter
Length	48 Millimeter
Width	5 Millimeter
Length	48 Millimeter
Width	5 Millimeter
Length	48 Millimeter
Width	5 Millimeter
Length	48 Millimeter
Width	5 Millimeter
Length	48 Millimeter
Width	5 Millimeter
Length	48 Millimeter
Width	5 Millimeter
Length	48 Millimeter
Width	5 Millimeter
Length	48 Millimeter
Width	5 Millimeter
Length	48 Millimeter
Width	5 Millimeter
Length	48 Millimeter
Width	5 Millimeter
Length	48 Millimeter
Width	5 Millimeter
Length	48 Millimeter
Width	5 Millimeter
Length	48 Millimeter
Width	5 Millimeter
Length	48 Millimeter
Width	5 Millimeter
Length	48 Millimeter
Width	5 Millimeter
Length	48 Millimeter
Width	5 Millimeter
Length	48 Millimeter
Width	5 Millimeter
Length	48 Millimeter
Width	5 Millimeter
Length	48 Millimeter
Width	5 Millimeter
Length	48 Millimeter
Width	5 Millimeter
Length	48 Millimeter
Width	5 Millimeter
Length	48 Millimeter
Width	5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841379144557 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K171250

FDA Product Code

NKG	Posterior Cervical Screw System