BB093216A

GUDID 00841379101185

OTLIF SPACER

HYHTE HOLDINGS, INC.

Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage

Primary Device ID	00841379101185
NIH Device Record Key	a5af9cb8-83f4-48e3-981b-922e074ea59d
Commercial Distribution Status	In Commercial Distribution
Version Model Number	BB093216A
Catalog Number	BB093216A
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

Width	9 Millimeter
Angle	0 degree
Height	16 Millimeter
Length	32 Millimeter
Width	9 Millimeter
Angle	0 degree
Height	16 Millimeter
Length	32 Millimeter
Width	9 Millimeter
Angle	0 degree
Height	16 Millimeter
Length	32 Millimeter
Width	9 Millimeter
Angle	0 degree
Height	16 Millimeter
Length	32 Millimeter
Width	9 Millimeter
Angle	0 degree
Height	16 Millimeter
Length	32 Millimeter
Width	9 Millimeter
Angle	0 degree
Height	16 Millimeter
Length	32 Millimeter
Width	9 Millimeter
Angle	0 degree
Height	16 Millimeter
Length	32 Millimeter
Width	9 Millimeter
Angle	0 degree
Height	16 Millimeter
Length	32 Millimeter
Width	9 Millimeter
Angle	0 degree
Height	16 Millimeter
Length	32 Millimeter
Width	9 Millimeter
Angle	0 degree
Height	16 Millimeter
Length	32 Millimeter
Width	9 Millimeter
Angle	0 degree
Height	16 Millimeter
Length	32 Millimeter
Width	9 Millimeter
Angle	0 degree
Height	16 Millimeter
Length	32 Millimeter
Width	9 Millimeter
Angle	0 degree
Height	16 Millimeter
Length	32 Millimeter
Width	9 Millimeter
Angle	0 degree
Height	16 Millimeter
Length	32 Millimeter
Width	9 Millimeter
Angle	0 degree
Height	16 Millimeter
Length	32 Millimeter
Width	9 Millimeter
Angle	0 degree
Height	16 Millimeter
Length	32 Millimeter
Width	9 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841379101185 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K152512

FDA Product Code

MAX	Intervertebral Fusion Device With Bone Graft, Lumbar