TZBA0100J

GUDID 00840085271571

COLUMN TRIAL 12MM

HYHTE HOLDINGS, INC.

Spinal implant trial
Primary Device ID00840085271571
NIH Device Record Key86467303-7389-47e6-8622-9d32e10ce405
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberTZBA0100J
Catalog NumberTZBA0100J
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
EmailTROY@ASTURAMEDICAL.COM
Phone7608148047
EmailTROY@ASTURAMEDICAL.COM
Phone7608148047
EmailTROY@ASTURAMEDICAL.COM
Phone7608148047
EmailTROY@ASTURAMEDICAL.COM
Phone7608148047
EmailTROY@ASTURAMEDICAL.COM
Phone7608148047
EmailTROY@ASTURAMEDICAL.COM
Phone7608148047
EmailTROY@ASTURAMEDICAL.COM
Phone7608148047
EmailTROY@ASTURAMEDICAL.COM
Phone7608148047
EmailTROY@ASTURAMEDICAL.COM
Phone7608148047
EmailTROY@ASTURAMEDICAL.COM
Phone7608148047
EmailTROY@ASTURAMEDICAL.COM
Phone7608148047
EmailTROY@ASTURAMEDICAL.COM
Phone7608148047
EmailTROY@ASTURAMEDICAL.COM

Device Dimensions

Outer Diameter12 Millimeter
Height81 Millimeter
Outer Diameter12 Millimeter
Height81 Millimeter
Outer Diameter12 Millimeter
Height81 Millimeter
Outer Diameter12 Millimeter
Height81 Millimeter
Outer Diameter12 Millimeter
Height81 Millimeter
Outer Diameter12 Millimeter
Height81 Millimeter
Outer Diameter12 Millimeter
Height81 Millimeter
Outer Diameter12 Millimeter
Height81 Millimeter
Outer Diameter12 Millimeter
Height81 Millimeter
Outer Diameter12 Millimeter
Height81 Millimeter
Outer Diameter12 Millimeter
Height81 Millimeter
Outer Diameter12 Millimeter
Height81 Millimeter
Outer Diameter12 Millimeter
Height81 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100840085271571 [Primary]

FDA Product Code

ODPIntervertebral Fusion Device With Bone Graft, Cervical

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840085271571]

Moist Heat or Steam Sterilization

[00840085271571]

Moist Heat or Steam Sterilization

[00840085271571]

Moist Heat or Steam Sterilization

[00840085271571]

Moist Heat or Steam Sterilization

[00840085271571]

Moist Heat or Steam Sterilization

[00840085271571]

Moist Heat or Steam Sterilization

[00840085271571]

Moist Heat or Steam Sterilization

[00840085271571]

Moist Heat or Steam Sterilization

[00840085271571]

Moist Heat or Steam Sterilization

[00840085271571]

Moist Heat or Steam Sterilization

[00840085271571]

Moist Heat or Steam Sterilization

[00840085271571]

Moist Heat or Steam Sterilization

[00840085271571]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-10-30
Device Publish Date2024-10-22

Devices Manufactured by HYHTE HOLDINGS, INC.

00840085272509 - NA2024-11-06 ENDPLATE, 20MM, VARIABLE LORDISIS, LATERAL, FULL, R.
00840085273322 - NA2024-11-06 ENDPLATE, 16MM, VARIABLE LORDOSIS, LATERAL, FULL, L.
00840085273339 - NA2024-11-06 ENDPLATE, 16MM, VARIABLE LORDOSIS, LATERAL, FULL, L.
00840085273346 - NA2024-11-06 ENDPLATE, 16MM, VARIABLE LORDOSIS, LATERAL, FULL, L.
00840085273353 - NA2024-11-06 ENDPLATE, 16MM, VARIABLE LORDOSIS, LATERAL, FULL, L.
00840085273360 - NA2024-11-06 ENDPLATE, 16MM, VARIABLE LORDOSIS, LATERAL, FULL, L.
00840085273377 - NA2024-11-06 ENDPLATE, 16MM, VARIABLE LORDOSIS, LATERAL, FULL, L.
00840085273384 - NA2024-11-06 ENDPLATE, 16MM, VARIABLE LORDOSIS, LATERAL, FULL, L.
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