GZC10C12B

GUDID 00840085210648

LLIF IMPLANT TRIAL, MODULAR, ANGLED LEFT

HYHTE HOLDINGS, INC.

Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial
Primary Device ID00840085210648
NIH Device Record Keyfc8adfa4-3bec-4f4a-8c91-e1392b0b0f27
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberGZC10C12B
Catalog NumberGZC10C12B
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

Device Dimensions

Width22 Millimeter
Height12 Millimeter
Angle7 degree
Width22 Millimeter
Height12 Millimeter
Angle7 degree
Width22 Millimeter
Height12 Millimeter
Angle7 degree
Width22 Millimeter
Height12 Millimeter
Angle7 degree
Width22 Millimeter
Height12 Millimeter
Angle7 degree
Width22 Millimeter
Height12 Millimeter
Angle7 degree
Width22 Millimeter
Height12 Millimeter
Angle7 degree
Width22 Millimeter
Height12 Millimeter
Angle7 degree
Width22 Millimeter
Height12 Millimeter
Angle7 degree
Width22 Millimeter
Height12 Millimeter
Angle7 degree
Width22 Millimeter
Height12 Millimeter
Angle7 degree
Width22 Millimeter
Height12 Millimeter
Angle7 degree
Width22 Millimeter
Height12 Millimeter
Angle7 degree
Width22 Millimeter
Height12 Millimeter
Angle7 degree
Width22 Millimeter
Height12 Millimeter
Angle7 degree

Device Identifiers

Device Issuing AgencyDevice ID
GS100840085210648 [Primary]

FDA Product Code

OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840085210648]

Moist Heat or Steam Sterilization


[00840085210648]

Moist Heat or Steam Sterilization


[00840085210648]

Moist Heat or Steam Sterilization


[00840085210648]

Moist Heat or Steam Sterilization


[00840085210648]

Moist Heat or Steam Sterilization


[00840085210648]

Moist Heat or Steam Sterilization


[00840085210648]

Moist Heat or Steam Sterilization


[00840085210648]

Moist Heat or Steam Sterilization


[00840085210648]

Moist Heat or Steam Sterilization


[00840085210648]

Moist Heat or Steam Sterilization


[00840085210648]

Moist Heat or Steam Sterilization


[00840085210648]

Moist Heat or Steam Sterilization


[00840085210648]

Moist Heat or Steam Sterilization


[00840085210648]

Moist Heat or Steam Sterilization


[00840085210648]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-07-22
Device Publish Date2021-07-14

Devices Manufactured by HYHTE HOLDINGS, INC.

00841379141600 - NA2021-07-27 POLYAXIAL SCREW #1, HIGH TOP
00841379141617 - NA2021-07-27 POLYAXIAL SCREW #1, HIGH TOP
00841379141624 - NA2021-07-27 POLYAXIAL SCREW #1, HIGH TOP
00841379141631 - NA2021-07-27 POLYAXIAL SCREW #1, HIGH TOP
00841379141648 - NA2021-07-27 POLYAXIAL SCREW #1, HIGH TOP
00841379141655 - NA2021-07-27 POLYAXIAL SCREW #1, HIGH TOP
00841379141662 - NA2021-07-27 POLYAXIAL SCREW #1, HIGH TOP
00841379141679 - NA2021-07-27 POLYAXIAL SCREW #1, HIGH TOP

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.