BH112807B

GUDID 00841379181163

OTLIF SPACER, EXPANDABLE, NON-STERILE

HYHTE HOLDINGS, INC.

Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage
Primary Device ID00841379181163
NIH Device Record Key4d9c1afb-8cd7-4e7b-bcc9-967cd513e23e
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberBH112807B
Catalog NumberBH112807B
Company DUNS073029645
Company NameHYHTE HOLDINGS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone7608148047
EmailTROY@ASTURAMEDICAL.COM
Phone7608148047
EmailTROY@ASTURAMEDICAL.COM
Phone7608148047
EmailTROY@ASTURAMEDICAL.COM
Phone7608148047
EmailTROY@ASTURAMEDICAL.COM
Phone7608148047
EmailTROY@ASTURAMEDICAL.COM
Phone7608148047
EmailTROY@ASTURAMEDICAL.COM
Phone7608148047
EmailTROY@ASTURAMEDICAL.COM

Device Dimensions

Width11 Millimeter
Length28 Millimeter
Height10.5 Millimeter
Angle3 degree
Width11 Millimeter
Length28 Millimeter
Height10.5 Millimeter
Angle3 degree
Width11 Millimeter
Length28 Millimeter
Height10.5 Millimeter
Angle3 degree
Width11 Millimeter
Length28 Millimeter
Height10.5 Millimeter
Angle3 degree
Width11 Millimeter
Length28 Millimeter
Height10.5 Millimeter
Angle3 degree
Width11 Millimeter
Length28 Millimeter
Height10.5 Millimeter
Angle3 degree
Width11 Millimeter
Length28 Millimeter
Height10.5 Millimeter
Angle3 degree

Device Identifiers

Device Issuing AgencyDevice ID
GS100841379181163 [Primary]

FDA Product Code

MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841379181163]

Moist Heat or Steam Sterilization


[00841379181163]

Moist Heat or Steam Sterilization


[00841379181163]

Moist Heat or Steam Sterilization


[00841379181163]

Moist Heat or Steam Sterilization


[00841379181163]

Moist Heat or Steam Sterilization


[00841379181163]

Moist Heat or Steam Sterilization


[00841379181163]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-08-11
Device Publish Date2021-08-03

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