BA102614B

GUDID 00841379100188

TLIF SPACER

HYHTE HOLDINGS, INC.

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Primary Device ID00841379100188
NIH Device Record Keydcdce6da-fcc7-4fde-a9a2-0392530f8305
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberBA102614B
Catalog NumberBA102614B
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
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
Phone7608148047
EmailTROY@ASTURAMEDICAL.COM
Phone7608148047
EmailTROY@ASTURAMEDICAL.COM
Phone7608148047
EmailTROY@ASTURAMEDICAL.COM

Device Dimensions

Width10 Millimeter
Angle5 degree
Height14 Millimeter
Length26 Millimeter
Width10 Millimeter
Angle5 degree
Height14 Millimeter
Length26 Millimeter
Width10 Millimeter
Angle5 degree
Height14 Millimeter
Length26 Millimeter
Width10 Millimeter
Angle5 degree
Height14 Millimeter
Length26 Millimeter
Width10 Millimeter
Angle5 degree
Height14 Millimeter
Length26 Millimeter
Width10 Millimeter
Angle5 degree
Height14 Millimeter
Length26 Millimeter
Width10 Millimeter
Angle5 degree
Height14 Millimeter
Length26 Millimeter
Width10 Millimeter
Angle5 degree
Height14 Millimeter
Length26 Millimeter
Width10 Millimeter
Angle5 degree
Height14 Millimeter
Length26 Millimeter
Width10 Millimeter
Angle5 degree
Height14 Millimeter
Length26 Millimeter
Width10 Millimeter
Angle5 degree
Height14 Millimeter
Length26 Millimeter
Width10 Millimeter
Angle5 degree
Height14 Millimeter
Length26 Millimeter
Width10 Millimeter
Angle5 degree
Height14 Millimeter
Length26 Millimeter
Width10 Millimeter
Angle5 degree
Height14 Millimeter
Length26 Millimeter
Width10 Millimeter
Angle5 degree
Height14 Millimeter
Length26 Millimeter
Width10 Millimeter
Angle5 degree
Height14 Millimeter
Length26 Millimeter
Width10 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100841379100188 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841379100188]

Moist Heat or Steam Sterilization


[00841379100188]

Moist Heat or Steam Sterilization


[00841379100188]

Moist Heat or Steam Sterilization


[00841379100188]

Moist Heat or Steam Sterilization


[00841379100188]

Moist Heat or Steam Sterilization


[00841379100188]

Moist Heat or Steam Sterilization


[00841379100188]

Moist Heat or Steam Sterilization


[00841379100188]

Moist Heat or Steam Sterilization


[00841379100188]

Moist Heat or Steam Sterilization


[00841379100188]

Moist Heat or Steam Sterilization


[00841379100188]

Moist Heat or Steam Sterilization


[00841379100188]

Moist Heat or Steam Sterilization


[00841379100188]

Moist Heat or Steam Sterilization


[00841379100188]

Moist Heat or Steam Sterilization


[00841379100188]

Moist Heat or Steam Sterilization


[00841379100188]

Moist Heat or Steam Sterilization


[00841379100188]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-02-24
Device Publish Date2016-09-09

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