GZC10E20A

GUDID 00840085211362

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 ID00840085211362
NIH Device Record Keyf9f28094-bb30-43dd-810e-c4d37ed87a9f
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberGZC10E20A
Catalog NumberGZC10E20A
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
Height20 Millimeter
Angle0 degree
Width26 Millimeter
Height20 Millimeter
Angle0 degree
Width26 Millimeter
Height20 Millimeter
Angle0 degree
Width26 Millimeter
Height20 Millimeter
Angle0 degree
Width26 Millimeter
Height20 Millimeter
Angle0 degree
Width26 Millimeter
Height20 Millimeter
Angle0 degree
Width26 Millimeter
Height20 Millimeter
Angle0 degree
Width26 Millimeter
Height20 Millimeter
Angle0 degree
Width26 Millimeter
Height20 Millimeter
Angle0 degree
Width26 Millimeter
Height20 Millimeter
Angle0 degree
Width26 Millimeter
Height20 Millimeter
Angle0 degree
Width26 Millimeter
Height20 Millimeter
Angle0 degree
Width26 Millimeter
Height20 Millimeter
Angle0 degree
Width26 Millimeter
Height20 Millimeter
Angle0 degree
Width26 Millimeter
Height20 Millimeter
Angle0 degree

Device Identifiers

Device Issuing AgencyDevice ID
GS100840085211362 [Primary]

FDA Product Code

OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840085211362]

Moist Heat or Steam Sterilization


[00840085211362]

Moist Heat or Steam Sterilization


[00840085211362]

Moist Heat or Steam Sterilization


[00840085211362]

Moist Heat or Steam Sterilization


[00840085211362]

Moist Heat or Steam Sterilization


[00840085211362]

Moist Heat or Steam Sterilization


[00840085211362]

Moist Heat or Steam Sterilization


[00840085211362]

Moist Heat or Steam Sterilization


[00840085211362]

Moist Heat or Steam Sterilization


[00840085211362]

Moist Heat or Steam Sterilization


[00840085211362]

Moist Heat or Steam Sterilization


[00840085211362]

Moist Heat or Steam Sterilization


[00840085211362]

Moist Heat or Steam Sterilization


[00840085211362]

Moist Heat or Steam Sterilization


[00840085211362]

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.

00840085254413 - NA2024-05-07 POLYAXIAL, TULIP
00840085254420 - NA2024-05-07 POLYAXIAL, HIGH TOP, TULIP
00840085254437 - NA2024-05-07 POLYAXIAL, EXTENDED TAB, TULIP
00840085254444 - NA2024-05-07 FAVORED ANGLE M/L, TULIP
00840085254451 - NA2024-05-07 FAVORED ANGLE M/L, HIGH TOP, TULIP
00840085254468 - NA2024-05-07 FAVORED ANGLE M/L, EXTENED TAB, TULIP
00840085254475 - NA2024-05-07 FAVORED ANGLE C/C, TULIP
00840085254482 - NA2024-05-07 FAVORED ANGLE C/C, HIGH TOP, TULIP

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