N/A BE102608B

GUDID 00841379164043

TLIF 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 ID00841379164043
NIH Device Record Key17561b5a-647e-41a3-ad2a-53d3df85044d
Commercial Distribution StatusIn Commercial Distribution
Brand NameN/A
Version Model NumberBE102608B
Catalog NumberBE102608B
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
EmailPARKER@ASTURAMEDICAL.COM
Phone7608148047
EmailPARKER@ASTURAMEDICAL.COM
Phone7608148047
EmailPARKER@ASTURAMEDICAL.COM
Phone7608148047
EmailPARKER@ASTURAMEDICAL.COM
Phone7608148047
EmailPARKER@ASTURAMEDICAL.COM
Phone7608148047
EmailPARKER@ASTURAMEDICAL.COM
Phone7608148047
EmailPARKER@ASTURAMEDICAL.COM
Phone7608148047
EmailPARKER@ASTURAMEDICAL.COM
Phone7608148047
EmailPARKER@ASTURAMEDICAL.COM
Phone7608148047
EmailPARKER@ASTURAMEDICAL.COM
Phone7608148047
EmailPARKER@ASTURAMEDICAL.COM
Phone7608148047
EmailPARKER@ASTURAMEDICAL.COM
Phone7608148047
EmailPARKER@ASTURAMEDICAL.COM
Phone7608148047
EmailPARKER@ASTURAMEDICAL.COM
Phone7608148047
EmailPARKER@ASTURAMEDICAL.COM
Phone7608148047
EmailPARKER@ASTURAMEDICAL.COM
Phone7608148047
EmailPARKER@ASTURAMEDICAL.COM

Device Dimensions

Angle5 degree
Width10 Millimeter
Length26 Millimeter
Height8 Millimeter
Angle5 degree
Width10 Millimeter
Length26 Millimeter
Height8 Millimeter
Angle5 degree
Width10 Millimeter
Length26 Millimeter
Height8 Millimeter
Angle5 degree
Width10 Millimeter
Length26 Millimeter
Height8 Millimeter
Angle5 degree
Width10 Millimeter
Length26 Millimeter
Height8 Millimeter
Angle5 degree
Width10 Millimeter
Length26 Millimeter
Height8 Millimeter
Angle5 degree
Width10 Millimeter
Length26 Millimeter
Height8 Millimeter
Angle5 degree
Width10 Millimeter
Length26 Millimeter
Height8 Millimeter
Angle5 degree
Width10 Millimeter
Length26 Millimeter
Height8 Millimeter
Angle5 degree
Width10 Millimeter
Length26 Millimeter
Height8 Millimeter
Angle5 degree
Width10 Millimeter
Length26 Millimeter
Height8 Millimeter
Angle5 degree
Width10 Millimeter
Length26 Millimeter
Height8 Millimeter
Angle5 degree
Width10 Millimeter
Length26 Millimeter
Height8 Millimeter
Angle5 degree
Width10 Millimeter
Length26 Millimeter
Height8 Millimeter
Angle5 degree
Width10 Millimeter
Length26 Millimeter
Height8 Millimeter
Angle5 degree
Width10 Millimeter
Length26 Millimeter
Height8 Millimeter
Angle5 degree

Device Identifiers

Device Issuing AgencyDevice ID
GS100841379164043 [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

[00841379164043]

Moist Heat or Steam Sterilization


[00841379164043]

Moist Heat or Steam Sterilization


[00841379164043]

Moist Heat or Steam Sterilization


[00841379164043]

Moist Heat or Steam Sterilization


[00841379164043]

Moist Heat or Steam Sterilization


[00841379164043]

Moist Heat or Steam Sterilization


[00841379164043]

Moist Heat or Steam Sterilization


[00841379164043]

Moist Heat or Steam Sterilization


[00841379164043]

Moist Heat or Steam Sterilization


[00841379164043]

Moist Heat or Steam Sterilization


[00841379164043]

Moist Heat or Steam Sterilization


[00841379164043]

Moist Heat or Steam Sterilization


[00841379164043]

Moist Heat or Steam Sterilization


[00841379164043]

Moist Heat or Steam Sterilization


[00841379164043]

Moist Heat or Steam Sterilization


[00841379164043]

Moist Heat or Steam Sterilization


[00841379164043]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-02-24
Device Publish Date2018-02-16

On-Brand Devices [N/A]

00841379164388TLIF SPACER
00841379164371TLIF SPACER
00841379164364TLIF SPACER
00841379164357TLIF SPACER
00841379164340TLIF SPACER
00841379164333TLIF SPACER
00841379164326TLIF SPACER
00841379164319TLIF SPACER
00841379164302TLIF SPACER
00841379164296TLIF SPACER
00841379164289TLIF SPACER
00841379164272TLIF SPACER
00841379164265TLIF SPACER
00841379164258TLIF SPACER
00841379164241TLIF SPACER
00841379164234TLIF SPACER
00841379164227TLIF SPACER
00841379164210TLIF SPACER
00841379164203TLIF SPACER
00841379164197TLIF SPACER
00841379164180TLIF SPACER
00841379164173TLIF SPACER
00841379164166TLIF SPACER
00841379164159TLIF SPACER
00841379164142TLIF SPACER
00841379164135TLIF SPACER
00841379164128TLIF SPACER
00841379164111TLIF SPACER
00841379164104TLIF SPACER
00841379164098TLIF SPACER
00841379164081TLIF SPACER
00841379164074TLIF SPACER
00841379164067TLIF SPACER
00841379164050TLIF SPACER
00841379164043TLIF SPACER
00841379164036TLIF SPACER
00841379139898OTLIF SPACER, PEEK, 10MMX22MMX08MMX5°, NON-STERILE
00841379100614OTLIF SPACER, PEEK, 10MMX22MMX14MMX5°, NON-STERILE
00841379100607OTLIF SPACER, PEEK, 10MMX22MMX13MMX5°, NON-STERILE
00841379100584OTLIF SPACER, PEEK, 10MMX22MMX11MMX5°, NON-STERILE
00841379100577OTLIF SPACER, PEEK, 10MMX22MMX10MMX5°, NON-STERILE
00841379100560OTLIF SPACER, PEEK, 10MMX22MMX09MMX5°, NON-STERILE
00841379100553OTLIF SPACER, PEEK, 10MMX22MMX07MMX5°, NON-STERILE
00841379100546TLIF SPACER
00841379100539TLIF SPACER
00841379100522TLIF SPACER
00841379100515TLIF SPACER
00841379100508TLIF SPACER
00841379100492TLIF SPACER
00841379100485TLIF SPACER

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