GZC01A10D

GUDID 00840085207761

LLIF IMPLANT TRIAL, MODULAR, STRAIGHT

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 ID00840085207761
NIH Device Record Keycdb79838-753f-4c4a-bf8d-cd123fbac633
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberGZC01A10D
Catalog NumberGZC01A10D
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

Width18 Millimeter
Height10 Millimeter
Angle15 degree
Width18 Millimeter
Height10 Millimeter
Angle15 degree
Width18 Millimeter
Height10 Millimeter
Angle15 degree
Width18 Millimeter
Height10 Millimeter
Angle15 degree
Width18 Millimeter
Height10 Millimeter
Angle15 degree
Width18 Millimeter
Height10 Millimeter
Angle15 degree
Width18 Millimeter
Height10 Millimeter
Angle15 degree
Width18 Millimeter
Height10 Millimeter
Angle15 degree
Width18 Millimeter
Height10 Millimeter
Angle15 degree
Width18 Millimeter
Height10 Millimeter
Angle15 degree
Width18 Millimeter
Height10 Millimeter
Angle15 degree
Width18 Millimeter
Height10 Millimeter
Angle15 degree
Width18 Millimeter
Height10 Millimeter
Angle15 degree
Width18 Millimeter
Height10 Millimeter
Angle15 degree
Width18 Millimeter
Height10 Millimeter
Angle15 degree

Device Identifiers

Device Issuing AgencyDevice ID
GS100840085207761 [Primary]

FDA Product Code

OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840085207761]

Moist Heat or Steam Sterilization


[00840085207761]

Moist Heat or Steam Sterilization


[00840085207761]

Moist Heat or Steam Sterilization


[00840085207761]

Moist Heat or Steam Sterilization


[00840085207761]

Moist Heat or Steam Sterilization


[00840085207761]

Moist Heat or Steam Sterilization


[00840085207761]

Moist Heat or Steam Sterilization


[00840085207761]

Moist Heat or Steam Sterilization


[00840085207761]

Moist Heat or Steam Sterilization


[00840085207761]

Moist Heat or Steam Sterilization


[00840085207761]

Moist Heat or Steam Sterilization


[00840085207761]

Moist Heat or Steam Sterilization


[00840085207761]

Moist Heat or Steam Sterilization


[00840085207761]

Moist Heat or Steam Sterilization


[00840085207761]

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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00840085265501 - NA2024-04-25 CORTICAL CANCELLOUS CANNULATED SCREW
00840085265518 - NA2024-04-25 CORTICAL CANCELLOUS CANNULATED SCREW
00840085265525 - NA2024-04-25 CORTICAL CANCELLOUS CANNULATED SCREW
00840085265532 - NA2024-04-25 CORTICAL CANCELLOUS CANNULATED SCREW
00840085265549 - NA2024-04-25 CORTICAL CANCELLOUS CANNULATED SCREW
00840085265556 - NA2024-04-25 CORTICAL CANCELLOUS CANNULATED SCREW

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