LZFSAA06A

GUDID 00840085233623

ZERO PLATE TRIAL

HYHTE HOLDINGS, INC.

Spinal fixation plate, non-bioabsorbable
Primary Device ID00840085233623
NIH Device Record Key7e7db2d6-2f8c-47a7-92e1-85f620fa76ac
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberLZFSAA06A
Catalog NumberLZFSAA06A
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
Phone7608148047
EmailPARKER@ASTURAMEDICAL.COM
Phone7608148047
EmailPARKER@ASTURAMEDICAL.COM
Phone7608148047
EmailPARKER@ASTURAMEDICAL.COM
Phone7608148047
EmailPARKER@ASTURAMEDICAL.COM
Phone7608148047
EmailPARKER@ASTURAMEDICAL.COM

Device Dimensions

Width14 Millimeter
Length12 Millimeter
Height6 Millimeter
Angle7 degree
Width14 Millimeter
Length12 Millimeter
Height6 Millimeter
Angle7 degree
Width14 Millimeter
Length12 Millimeter
Height6 Millimeter
Angle7 degree
Width14 Millimeter
Length12 Millimeter
Height6 Millimeter
Angle7 degree
Width14 Millimeter
Length12 Millimeter
Height6 Millimeter
Angle7 degree
Width14 Millimeter
Length12 Millimeter
Height6 Millimeter
Angle7 degree
Width14 Millimeter
Length12 Millimeter
Height6 Millimeter
Angle7 degree
Width14 Millimeter
Length12 Millimeter
Height6 Millimeter
Angle7 degree
Width14 Millimeter
Length12 Millimeter
Height6 Millimeter
Angle7 degree
Width14 Millimeter
Length12 Millimeter
Height6 Millimeter
Angle7 degree
Width14 Millimeter
Length12 Millimeter
Height6 Millimeter
Angle7 degree
Width14 Millimeter
Length12 Millimeter
Height6 Millimeter
Angle7 degree
Width14 Millimeter
Length12 Millimeter
Height6 Millimeter
Angle7 degree
Width14 Millimeter
Length12 Millimeter
Height6 Millimeter
Angle7 degree
Width14 Millimeter
Length12 Millimeter
Height6 Millimeter
Angle7 degree
Width14 Millimeter
Length12 Millimeter
Height6 Millimeter
Angle7 degree
Width14 Millimeter
Length12 Millimeter
Height6 Millimeter
Angle7 degree
Width14 Millimeter
Length12 Millimeter
Height6 Millimeter
Angle7 degree
Width14 Millimeter
Length12 Millimeter
Height6 Millimeter
Angle7 degree
Width14 Millimeter
Length12 Millimeter
Height6 Millimeter
Angle7 degree

Device Identifiers

Device Issuing AgencyDevice ID
GS100840085233623 [Primary]

FDA Product Code

OVEIntervertebral Fusion Device With Integrated Fixation, Cervical

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840085233623]

Moist Heat or Steam Sterilization


[00840085233623]

Moist Heat or Steam Sterilization


[00840085233623]

Moist Heat or Steam Sterilization


[00840085233623]

Moist Heat or Steam Sterilization


[00840085233623]

Moist Heat or Steam Sterilization


[00840085233623]

Moist Heat or Steam Sterilization


[00840085233623]

Moist Heat or Steam Sterilization


[00840085233623]

Moist Heat or Steam Sterilization


[00840085233623]

Moist Heat or Steam Sterilization


[00840085233623]

Moist Heat or Steam Sterilization


[00840085233623]

Moist Heat or Steam Sterilization


[00840085233623]

Moist Heat or Steam Sterilization


[00840085233623]

Moist Heat or Steam Sterilization


[00840085233623]

Moist Heat or Steam Sterilization


[00840085233623]

Moist Heat or Steam Sterilization


[00840085233623]

Moist Heat or Steam Sterilization


[00840085233623]

Moist Heat or Steam Sterilization


[00840085233623]

Moist Heat or Steam Sterilization


[00840085233623]

Moist Heat or Steam Sterilization


[00840085233623]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-08-04
Device Publish Date2021-07-27

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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