TA1205381

GUDID 00840085271021

EXPANDABLE COLUMN

HYHTE HOLDINGS, INC.

Metallic spinal interbody fusion cage
Primary Device ID00840085271021
NIH Device Record Keyf15b7bb6-c601-4fdf-b539-f7256aca837d
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberTA1205381
Catalog NumberTA1205381
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
GS100840085271021 [Primary]

FDA Product Code

ODPIntervertebral Fusion Device With Bone Graft, Cervical

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840085271021]

Moist Heat or Steam Sterilization


[00840085271021]

Moist Heat or Steam Sterilization


[00840085271021]

Moist Heat or Steam Sterilization


[00840085271021]

Moist Heat or Steam Sterilization


[00840085271021]

Moist Heat or Steam Sterilization


[00840085271021]

Moist Heat or Steam Sterilization


[00840085271021]

Moist Heat or Steam Sterilization


[00840085271021]

Moist Heat or Steam Sterilization


[00840085271021]

Moist Heat or Steam Sterilization


[00840085271021]

Moist Heat or Steam Sterilization


[00840085271021]

Moist Heat or Steam Sterilization


[00840085271021]

Moist Heat or Steam Sterilization


[00840085271021]

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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