BB092407A

GUDID 00841379100652

OTLIF SPACER

HYHTE HOLDINGS, INC.

Polymeric spinal interbody fusion cage
Primary Device ID00841379100652
NIH Device Record Keyb026bad8-8935-4708-8748-803d8926df72
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberBB092407A
Catalog NumberBB092407A
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

Width9 Millimeter
Angle0 degree
Height7 Millimeter
Length24 Millimeter
Width9 Millimeter
Angle0 degree
Height7 Millimeter
Length24 Millimeter
Width9 Millimeter
Angle0 degree
Height7 Millimeter
Length24 Millimeter
Width9 Millimeter
Angle0 degree
Height7 Millimeter
Length24 Millimeter
Width9 Millimeter
Angle0 degree
Height7 Millimeter
Length24 Millimeter
Width9 Millimeter
Angle0 degree
Height7 Millimeter
Length24 Millimeter
Width9 Millimeter
Angle0 degree
Height7 Millimeter
Length24 Millimeter
Width9 Millimeter
Angle0 degree
Height7 Millimeter
Length24 Millimeter
Width9 Millimeter
Angle0 degree
Height7 Millimeter
Length24 Millimeter
Width9 Millimeter
Angle0 degree
Height7 Millimeter
Length24 Millimeter
Width9 Millimeter
Angle0 degree
Height7 Millimeter
Length24 Millimeter
Width9 Millimeter
Angle0 degree
Height7 Millimeter
Length24 Millimeter
Width9 Millimeter
Angle0 degree
Height7 Millimeter
Length24 Millimeter
Width9 Millimeter
Angle0 degree
Height7 Millimeter
Length24 Millimeter
Width9 Millimeter
Angle0 degree
Height7 Millimeter
Length24 Millimeter
Width9 Millimeter
Angle0 degree
Height7 Millimeter
Length24 Millimeter
Width9 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100841379100652 [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

[00841379100652]

Moist Heat or Steam Sterilization


[00841379100652]

Moist Heat or Steam Sterilization


[00841379100652]

Moist Heat or Steam Sterilization


[00841379100652]

Moist Heat or Steam Sterilization


[00841379100652]

Moist Heat or Steam Sterilization


[00841379100652]

Moist Heat or Steam Sterilization


[00841379100652]

Moist Heat or Steam Sterilization


[00841379100652]

Moist Heat or Steam Sterilization


[00841379100652]

Moist Heat or Steam Sterilization


[00841379100652]

Moist Heat or Steam Sterilization


[00841379100652]

Moist Heat or Steam Sterilization


[00841379100652]

Moist Heat or Steam Sterilization


[00841379100652]

Moist Heat or Steam Sterilization


[00841379100652]

Moist Heat or Steam Sterilization


[00841379100652]

Moist Heat or Steam Sterilization


[00841379100652]

Moist Heat or Steam Sterilization


[00841379100652]

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

Devices Manufactured by HYHTE HOLDINGS, INC.

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00840085242458 - NA2024-09-11 FULL PLATE INSERTER
00840085242472 - NA2024-09-11 NAIL INSERTION TOOL
00840085268496 - NA2024-08-21 SI SCREW, FIXED, COMPRESSION THREAD, ASTURABOND FINISH
00840085268502 - NA2024-08-21 SI SCREW, FIXED, COMPRESSION THREAD, ASTURABOND FINISH
00840085268519 - NA2024-08-21 SI SCREW, FIXED, COMPRESSION THREAD, ASTURABOND FINISH

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