GZC01C08D

GUDID 00840085208348

LLIF IMPLANT TRIAL, MODULAR, STRAIGHT

HYHTE HOLDINGS, INC.

Spinal implant trial
Primary Device ID00840085208348
NIH Device Record Keye1cfafa1-cd49-4515-9e27-2ab3898b2572
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberGZC01C08D
Catalog NumberGZC01C08D
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
Height8 Millimeter
Angle15 degree
Width22 Millimeter
Height8 Millimeter
Angle15 degree
Width22 Millimeter
Height8 Millimeter
Angle15 degree
Width22 Millimeter
Height8 Millimeter
Angle15 degree
Width22 Millimeter
Height8 Millimeter
Angle15 degree
Width22 Millimeter
Height8 Millimeter
Angle15 degree
Width22 Millimeter
Height8 Millimeter
Angle15 degree
Width22 Millimeter
Height8 Millimeter
Angle15 degree
Width22 Millimeter
Height8 Millimeter
Angle15 degree
Width22 Millimeter
Height8 Millimeter
Angle15 degree
Width22 Millimeter
Height8 Millimeter
Angle15 degree
Width22 Millimeter
Height8 Millimeter
Angle15 degree
Width22 Millimeter
Height8 Millimeter
Angle15 degree
Width22 Millimeter
Height8 Millimeter
Angle15 degree
Width22 Millimeter
Height8 Millimeter
Angle15 degree

Device Identifiers

Device Issuing AgencyDevice ID
GS100840085208348 [Primary]

FDA Product Code

OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840085208348]

Moist Heat or Steam Sterilization

[00840085208348]

Moist Heat or Steam Sterilization

[00840085208348]

Moist Heat or Steam Sterilization

[00840085208348]

Moist Heat or Steam Sterilization

[00840085208348]

Moist Heat or Steam Sterilization

[00840085208348]

Moist Heat or Steam Sterilization

[00840085208348]

Moist Heat or Steam Sterilization

[00840085208348]

Moist Heat or Steam Sterilization

[00840085208348]

Moist Heat or Steam Sterilization

[00840085208348]

Moist Heat or Steam Sterilization

[00840085208348]

Moist Heat or Steam Sterilization

[00840085208348]

Moist Heat or Steam Sterilization

[00840085208348]

Moist Heat or Steam Sterilization

[00840085208348]

Moist Heat or Steam Sterilization

[00840085208348]

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.

00840085271861 - NA2025-03-06 EGPS, LUMBAR PEDICLE AWL
00840085271878 - NA2025-03-06 EGPS, LUMBAR PEDICLE PROBE, STRAIGHT
00840085271885 - NA2025-03-06 EGPS, LUMBAR PEDICLE PROBE, CURVED
00840085271892 - NA2025-03-06 EGPS, THORACIC PEDICLE PROBE, STRAIGHT
00840085271908 - NA2025-03-06 EGPS, THORACIC PEDICLE PROBE, CURVED
00840085271915 - NA2025-03-06 EGPS, REAMING PILOT DRILL, 3.5MM
00840085271922 - NA2025-03-06 EGPS, CORTICAL, TAP, 3.5MM
00840085271939 - NA2025-03-06 EGPS, CORTICAL, TAP, 4.0MM
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