GZC11A12A

GUDID 00840085212253

LLIF IMPLANT TRIAL, MODULAR, ANGLED RIGHT

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 ID00840085212253
NIH Device Record Key89e1caf8-9e5b-417a-91ee-322de7b7a4cd
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberGZC11A12A
Catalog NumberGZC11A12A
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

Width18 Millimeter
Height12 Millimeter
Angle0 degree
Width18 Millimeter
Height12 Millimeter
Angle0 degree
Width18 Millimeter
Height12 Millimeter
Angle0 degree
Width18 Millimeter
Height12 Millimeter
Angle0 degree
Width18 Millimeter
Height12 Millimeter
Angle0 degree
Width18 Millimeter
Height12 Millimeter
Angle0 degree
Width18 Millimeter
Height12 Millimeter
Angle0 degree
Width18 Millimeter
Height12 Millimeter
Angle0 degree
Width18 Millimeter
Height12 Millimeter
Angle0 degree
Width18 Millimeter
Height12 Millimeter
Angle0 degree
Width18 Millimeter
Height12 Millimeter
Angle0 degree
Width18 Millimeter
Height12 Millimeter
Angle0 degree
Width18 Millimeter
Height12 Millimeter
Angle0 degree
Width18 Millimeter
Height12 Millimeter
Angle0 degree
Width18 Millimeter
Height12 Millimeter
Angle0 degree

Device Identifiers

Device Issuing AgencyDevice ID
GS100840085212253 [Primary]

FDA Product Code

OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840085212253]

Moist Heat or Steam Sterilization


[00840085212253]

Moist Heat or Steam Sterilization


[00840085212253]

Moist Heat or Steam Sterilization


[00840085212253]

Moist Heat or Steam Sterilization


[00840085212253]

Moist Heat or Steam Sterilization


[00840085212253]

Moist Heat or Steam Sterilization


[00840085212253]

Moist Heat or Steam Sterilization


[00840085212253]

Moist Heat or Steam Sterilization


[00840085212253]

Moist Heat or Steam Sterilization


[00840085212253]

Moist Heat or Steam Sterilization


[00840085212253]

Moist Heat or Steam Sterilization


[00840085212253]

Moist Heat or Steam Sterilization


[00840085212253]

Moist Heat or Steam Sterilization


[00840085212253]

Moist Heat or Steam Sterilization


[00840085212253]

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.

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00841379149156 - N/A2021-07-29 POLYAXIAL SCREW ML #1
00841379149163 - N/A2021-07-29 POLYAXIAL SCREW ML #1
00841379149170 - N/A2021-07-29 POLYAXIAL SCREW ML #1
00841379149187 - N/A2021-07-29 POLYAXIAL SCREW ML #1
00841379149194 - N/A2021-07-29 POLYAXIAL SCREW ML #1
00841379149200 - N/A2021-07-29 POLYAXIAL SCREW ML #1

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