LZFSAA09B

GUDID 00840085233692

ZERO PLATE TRIAL

HYHTE HOLDINGS, INC.

Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable
Primary Device ID00840085233692
NIH Device Record Keyb4eedea0-e5b5-449c-a2eb-81f0a1abcff1
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberLZFSAA09B
Catalog NumberLZFSAA09B
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

Angle10 degree
Width14 Millimeter
Length12 Millimeter
Height9 Millimeter
Angle10 degree
Width14 Millimeter
Length12 Millimeter
Height9 Millimeter
Angle10 degree
Width14 Millimeter
Length12 Millimeter
Height9 Millimeter
Angle10 degree
Width14 Millimeter
Length12 Millimeter
Height9 Millimeter
Angle10 degree
Width14 Millimeter
Length12 Millimeter
Height9 Millimeter
Angle10 degree
Width14 Millimeter
Length12 Millimeter
Height9 Millimeter
Angle10 degree
Width14 Millimeter
Length12 Millimeter
Height9 Millimeter
Angle10 degree
Width14 Millimeter
Length12 Millimeter
Height9 Millimeter
Angle10 degree
Width14 Millimeter
Length12 Millimeter
Height9 Millimeter
Angle10 degree
Width14 Millimeter
Length12 Millimeter
Height9 Millimeter
Angle10 degree
Width14 Millimeter
Length12 Millimeter
Height9 Millimeter
Angle10 degree
Width14 Millimeter
Length12 Millimeter
Height9 Millimeter
Angle10 degree
Width14 Millimeter
Length12 Millimeter
Height9 Millimeter
Angle10 degree
Width14 Millimeter
Length12 Millimeter
Height9 Millimeter
Angle10 degree
Width14 Millimeter
Length12 Millimeter
Height9 Millimeter
Angle10 degree
Width14 Millimeter
Length12 Millimeter
Height9 Millimeter
Angle10 degree
Width14 Millimeter
Length12 Millimeter
Height9 Millimeter
Angle10 degree
Width14 Millimeter
Length12 Millimeter
Height9 Millimeter
Angle10 degree
Width14 Millimeter
Length12 Millimeter
Height9 Millimeter
Angle10 degree
Width14 Millimeter
Length12 Millimeter
Height9 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100840085233692 [Primary]

FDA Product Code

OVEIntervertebral Fusion Device With Integrated Fixation, Cervical

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840085233692]

Moist Heat or Steam Sterilization


[00840085233692]

Moist Heat or Steam Sterilization


[00840085233692]

Moist Heat or Steam Sterilization


[00840085233692]

Moist Heat or Steam Sterilization


[00840085233692]

Moist Heat or Steam Sterilization


[00840085233692]

Moist Heat or Steam Sterilization


[00840085233692]

Moist Heat or Steam Sterilization


[00840085233692]

Moist Heat or Steam Sterilization


[00840085233692]

Moist Heat or Steam Sterilization


[00840085233692]

Moist Heat or Steam Sterilization


[00840085233692]

Moist Heat or Steam Sterilization


[00840085233692]

Moist Heat or Steam Sterilization


[00840085233692]

Moist Heat or Steam Sterilization


[00840085233692]

Moist Heat or Steam Sterilization


[00840085233692]

Moist Heat or Steam Sterilization


[00840085233692]

Moist Heat or Steam Sterilization


[00840085233692]

Moist Heat or Steam Sterilization


[00840085233692]

Moist Heat or Steam Sterilization


[00840085233692]

Moist Heat or Steam Sterilization


[00840085233692]

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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00840085262722 - NA2024-02-23 SI SCREW TAP, STANDARD, Ø7MM
00840085262739 - NA2024-02-23 SI SCREW TAP, STANDARD, Ø8MM
00840085262746 - NA2024-02-23 SI SCREW TAP, STANDARD, Ø10MM
00840085262753 - NA2024-02-23 SI SCREW TAP, STANDARD, Ø12MM
00840085262760 - NA2024-02-23 SI SCREW TAP, STANDARD, Ø14MM

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