GZC10E12A

GUDID 00840085211201

LLIF IMPLANT TRIAL, MODULAR, ANGLED LEFT

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 ID00840085211201
NIH Device Record Keye5e3f297-b11a-4d94-a1da-248efdb4491c
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberGZC10E12A
Catalog NumberGZC10E12A
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

Width26 Millimeter
Height12 Millimeter
Angle0 degree
Width26 Millimeter
Height12 Millimeter
Angle0 degree
Width26 Millimeter
Height12 Millimeter
Angle0 degree
Width26 Millimeter
Height12 Millimeter
Angle0 degree
Width26 Millimeter
Height12 Millimeter
Angle0 degree
Width26 Millimeter
Height12 Millimeter
Angle0 degree
Width26 Millimeter
Height12 Millimeter
Angle0 degree
Width26 Millimeter
Height12 Millimeter
Angle0 degree
Width26 Millimeter
Height12 Millimeter
Angle0 degree
Width26 Millimeter
Height12 Millimeter
Angle0 degree
Width26 Millimeter
Height12 Millimeter
Angle0 degree
Width26 Millimeter
Height12 Millimeter
Angle0 degree
Width26 Millimeter
Height12 Millimeter
Angle0 degree
Width26 Millimeter
Height12 Millimeter
Angle0 degree
Width26 Millimeter
Height12 Millimeter
Angle0 degree

Device Identifiers

Device Issuing AgencyDevice ID
GS100840085211201 [Primary]

FDA Product Code

OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840085211201]

Moist Heat or Steam Sterilization


[00840085211201]

Moist Heat or Steam Sterilization


[00840085211201]

Moist Heat or Steam Sterilization


[00840085211201]

Moist Heat or Steam Sterilization


[00840085211201]

Moist Heat or Steam Sterilization


[00840085211201]

Moist Heat or Steam Sterilization


[00840085211201]

Moist Heat or Steam Sterilization


[00840085211201]

Moist Heat or Steam Sterilization


[00840085211201]

Moist Heat or Steam Sterilization


[00840085211201]

Moist Heat or Steam Sterilization


[00840085211201]

Moist Heat or Steam Sterilization


[00840085211201]

Moist Heat or Steam Sterilization


[00840085211201]

Moist Heat or Steam Sterilization


[00840085211201]

Moist Heat or Steam Sterilization


[00840085211201]

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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