TBF018150

GUDID 00840085271151

VARIABLE LORDOSIS FIXATED FULL ENDPLATE

HYHTE HOLDINGS, INC.

Cervical intervertebral disc prosthesis endplate
Primary Device ID00840085271151
NIH Device Record Key0840a695-8d51-4a7b-adcd-18af1f2bd50f
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberTBF018150
Catalog NumberTBF018150
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

Depth18 Millimeter
Length14 Millimeter
Outer Diameter12 Millimeter
Depth18 Millimeter
Length14 Millimeter
Outer Diameter12 Millimeter
Depth18 Millimeter
Length14 Millimeter
Outer Diameter12 Millimeter
Depth18 Millimeter
Length14 Millimeter
Outer Diameter12 Millimeter
Depth18 Millimeter
Length14 Millimeter
Outer Diameter12 Millimeter
Depth18 Millimeter
Length14 Millimeter
Outer Diameter12 Millimeter
Depth18 Millimeter
Length14 Millimeter
Outer Diameter12 Millimeter
Depth18 Millimeter
Length14 Millimeter
Outer Diameter12 Millimeter
Depth18 Millimeter
Length14 Millimeter
Outer Diameter12 Millimeter
Depth18 Millimeter
Length14 Millimeter
Outer Diameter12 Millimeter
Depth18 Millimeter
Length14 Millimeter
Outer Diameter12 Millimeter
Depth18 Millimeter
Length14 Millimeter
Outer Diameter12 Millimeter
Depth18 Millimeter
Length14 Millimeter
Outer Diameter12 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100840085271151 [Primary]

FDA Product Code

ODPIntervertebral Fusion Device With Bone Graft, Cervical

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840085271151]

Moist Heat or Steam Sterilization

[00840085271151]

Moist Heat or Steam Sterilization

[00840085271151]

Moist Heat or Steam Sterilization

[00840085271151]

Moist Heat or Steam Sterilization

[00840085271151]

Moist Heat or Steam Sterilization

[00840085271151]

Moist Heat or Steam Sterilization

[00840085271151]

Moist Heat or Steam Sterilization

[00840085271151]

Moist Heat or Steam Sterilization

[00840085271151]

Moist Heat or Steam Sterilization

[00840085271151]

Moist Heat or Steam Sterilization

[00840085271151]

Moist Heat or Steam Sterilization

[00840085271151]

Moist Heat or Steam Sterilization

[00840085271151]

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.

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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