GZC11B20D

GUDID 00840085212758

LLIF IMPLANT TRIAL, MODULAR, ANGLED RIGHT

HYHTE HOLDINGS, INC.

Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial
Primary Device ID00840085212758
NIH Device Record Keyfad4c7d6-2f94-4c24-b763-3d2dc793de5f
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberGZC11B20D
Catalog NumberGZC11B20D
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

Device Dimensions

Width20 Millimeter
Height20 Millimeter
Angle15 degree
Width20 Millimeter
Height20 Millimeter
Angle15 degree
Width20 Millimeter
Height20 Millimeter
Angle15 degree
Width20 Millimeter
Height20 Millimeter
Angle15 degree
Width20 Millimeter
Height20 Millimeter
Angle15 degree
Width20 Millimeter
Height20 Millimeter
Angle15 degree
Width20 Millimeter
Height20 Millimeter
Angle15 degree
Width20 Millimeter
Height20 Millimeter
Angle15 degree
Width20 Millimeter
Height20 Millimeter
Angle15 degree
Width20 Millimeter
Height20 Millimeter
Angle15 degree
Width20 Millimeter
Height20 Millimeter
Angle15 degree
Width20 Millimeter
Height20 Millimeter
Angle15 degree
Width20 Millimeter
Height20 Millimeter
Angle15 degree
Width20 Millimeter
Height20 Millimeter
Angle15 degree
Width20 Millimeter
Height20 Millimeter
Angle15 degree

Device Identifiers

Device Issuing AgencyDevice ID
GS100840085212758 [Primary]

FDA Product Code

MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840085212758]

Moist Heat or Steam Sterilization


[00840085212758]

Moist Heat or Steam Sterilization


[00840085212758]

Moist Heat or Steam Sterilization


[00840085212758]

Moist Heat or Steam Sterilization


[00840085212758]

Moist Heat or Steam Sterilization


[00840085212758]

Moist Heat or Steam Sterilization


[00840085212758]

Moist Heat or Steam Sterilization


[00840085212758]

Moist Heat or Steam Sterilization


[00840085212758]

Moist Heat or Steam Sterilization


[00840085212758]

Moist Heat or Steam Sterilization


[00840085212758]

Moist Heat or Steam Sterilization


[00840085212758]

Moist Heat or Steam Sterilization


[00840085212758]

Moist Heat or Steam Sterilization


[00840085212758]

Moist Heat or Steam Sterilization


[00840085212758]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-07-22
Device Publish Date2021-07-14

Devices Manufactured by HYHTE HOLDINGS, INC.

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00841379149156 - N/A2021-07-29 POLYAXIAL SCREW ML #1
00841379149163 - N/A2021-07-29 POLYAXIAL SCREW ML #1
00841379149170 - N/A2021-07-29 POLYAXIAL SCREW ML #1
00841379149187 - N/A2021-07-29 POLYAXIAL SCREW ML #1
00841379149194 - N/A2021-07-29 POLYAXIAL SCREW ML #1
00841379149200 - N/A2021-07-29 POLYAXIAL SCREW ML #1

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