TCB016600

GUDID 00840085273148

ENDPLATE, 16MM, VARIABLE LORDOSIS, LATERAL

HYHTE HOLDINGS, INC.

Metallic spinal interbody fusion cage

Primary Device ID	00840085273148
NIH Device Record Key	a99b287e-c96f-4f82-bf28-bd2ba0bb5350
Commercial Distribution Status	In Commercial Distribution
Version Model Number	TCB016600
Catalog Number	TCB016600
Company DUNS	073029645
Company Name	HYHTE HOLDINGS, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	7608148047
Email	TROY@ASTURAMEDICAL.COM
Phone	7608148047
Email	TROY@ASTURAMEDICAL.COM
Phone	7608148047
Email	TROY@ASTURAMEDICAL.COM
Phone	7608148047
Email	TROY@ASTURAMEDICAL.COM
Phone	7608148047
Email	TROY@ASTURAMEDICAL.COM
Phone	7608148047
Email	TROY@ASTURAMEDICAL.COM
Phone	7608148047
Email	TROY@ASTURAMEDICAL.COM
Phone	7608148047
Email	TROY@ASTURAMEDICAL.COM
Phone	7608148047
Email	TROY@ASTURAMEDICAL.COM
Phone	7608148047
Email	TROY@ASTURAMEDICAL.COM
Phone	7608148047
Email	TROY@ASTURAMEDICAL.COM
Phone	7608148047
Email	TROY@ASTURAMEDICAL.COM
Phone	7608148047
Email	TROY@ASTURAMEDICAL.COM
Phone	7608148047
Email	TROY@ASTURAMEDICAL.COM
Phone	7608148047
Email	TROY@ASTURAMEDICAL.COM
Phone	7608148047
Email	TROY@ASTURAMEDICAL.COM
Phone	7608148047
Email	TROY@ASTURAMEDICAL.COM
Phone	7608148047
Email	TROY@ASTURAMEDICAL.COM
Phone	7608148047
Email	TROY@ASTURAMEDICAL.COM
Phone	7608148047
Email	TROY@ASTURAMEDICAL.COM
Phone	7608148047
Email	TROY@ASTURAMEDICAL.COM
Phone	7608148047
Email	TROY@ASTURAMEDICAL.COM
Phone	7608148047
Email	TROY@ASTURAMEDICAL.COM
Phone	7608148047
Email	TROY@ASTURAMEDICAL.COM
Phone	7608148047
Email	TROY@ASTURAMEDICAL.COM
Phone	7608148047
Email	TROY@ASTURAMEDICAL.COM
Phone	7608148047
Email	TROY@ASTURAMEDICAL.COM
Phone	7608148047
Email	TROY@ASTURAMEDICAL.COM
Phone	7608148047
Email	TROY@ASTURAMEDICAL.COM
Phone	7608148047
Email	TROY@ASTURAMEDICAL.COM
Phone	7608148047
Email	TROY@ASTURAMEDICAL.COM
Phone	7608148047
Email	TROY@ASTURAMEDICAL.COM
Phone	7608148047
Email	TROY@ASTURAMEDICAL.COM

Device Dimensions

Height	60 Millimeter
Height	60 Millimeter
Height	60 Millimeter
Height	60 Millimeter
Height	60 Millimeter
Height	60 Millimeter
Height	60 Millimeter
Height	60 Millimeter
Height	60 Millimeter
Height	60 Millimeter
Height	60 Millimeter
Height	60 Millimeter
Height	60 Millimeter
Height	60 Millimeter
Height	60 Millimeter
Height	60 Millimeter
Height	60 Millimeter
Height	60 Millimeter
Height	60 Millimeter
Height	60 Millimeter
Height	60 Millimeter
Height	60 Millimeter
Height	60 Millimeter
Height	60 Millimeter
Height	60 Millimeter
Height	60 Millimeter
Height	60 Millimeter
Height	60 Millimeter
Height	60 Millimeter
Height	60 Millimeter
Height	60 Millimeter
Height	60 Millimeter
Height	60 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840085273148 [Primary]

FDA Product Code

LXH	Orthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[00840085273148]

Moist Heat or Steam Sterilization

[00840085273148]

Moist Heat or Steam Sterilization

[00840085273148]

Moist Heat or Steam Sterilization

[00840085273148]

Moist Heat or Steam Sterilization

[00840085273148]

Moist Heat or Steam Sterilization

[00840085273148]

Moist Heat or Steam Sterilization

[00840085273148]

Moist Heat or Steam Sterilization

[00840085273148]

Moist Heat or Steam Sterilization

[00840085273148]

Moist Heat or Steam Sterilization

[00840085273148]

Moist Heat or Steam Sterilization

[00840085273148]

Moist Heat or Steam Sterilization

[00840085273148]

Moist Heat or Steam Sterilization

[00840085273148]

Moist Heat or Steam Sterilization

[00840085273148]

Moist Heat or Steam Sterilization

[00840085273148]

Moist Heat or Steam Sterilization

[00840085273148]

Moist Heat or Steam Sterilization

[00840085273148]

Moist Heat or Steam Sterilization

[00840085273148]

Moist Heat or Steam Sterilization

[00840085273148]

Moist Heat or Steam Sterilization

[00840085273148]

Moist Heat or Steam Sterilization

[00840085273148]

Moist Heat or Steam Sterilization

[00840085273148]

Moist Heat or Steam Sterilization

[00840085273148]

Moist Heat or Steam Sterilization

[00840085273148]

Moist Heat or Steam Sterilization

[00840085273148]

Moist Heat or Steam Sterilization

[00840085273148]

Moist Heat or Steam Sterilization

[00840085273148]

Moist Heat or Steam Sterilization

[00840085273148]

Moist Heat or Steam Sterilization

[00840085273148]

Moist Heat or Steam Sterilization

[00840085273148]

Moist Heat or Steam Sterilization

[00840085273148]

Moist Heat or Steam Sterilization

[00840085273148]

Moist Heat or Steam Sterilization

[00840085273148]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2024-11-01
Device Publish Date	2024-10-24

Devices Manufactured by HYHTE HOLDINGS, INC.

00840085272509 - NA	2024-11-06 ENDPLATE, 20MM, VARIABLE LORDISIS, LATERAL, FULL, R.
00840085273322 - NA	2024-11-06 ENDPLATE, 16MM, VARIABLE LORDOSIS, LATERAL, FULL, L.
00840085273339 - NA	2024-11-06 ENDPLATE, 16MM, VARIABLE LORDOSIS, LATERAL, FULL, L.
00840085273346 - NA	2024-11-06 ENDPLATE, 16MM, VARIABLE LORDOSIS, LATERAL, FULL, L.
00840085273353 - NA	2024-11-06 ENDPLATE, 16MM, VARIABLE LORDOSIS, LATERAL, FULL, L.
00840085273360 - NA	2024-11-06 ENDPLATE, 16MM, VARIABLE LORDOSIS, LATERAL, FULL, L.
00840085273377 - NA	2024-11-06 ENDPLATE, 16MM, VARIABLE LORDOSIS, LATERAL, FULL, L.
00840085273384 - NA	2024-11-06 ENDPLATE, 16MM, VARIABLE LORDOSIS, LATERAL, FULL, L.

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