KF0000020

GUDID 00840085217845

ALIF NAIL

HYHTE HOLDINGS, INC.

Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable
Primary Device ID00840085217845
NIH Device Record Keye4938cc7-ff71-4a83-8dce-8a3955a3cceb
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberKF0000020
Catalog NumberKF0000020
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
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
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

Width5.5 Millimeter
Length20 Millimeter
Width5.5 Millimeter
Length20 Millimeter
Width5.5 Millimeter
Length20 Millimeter
Width5.5 Millimeter
Length20 Millimeter
Width5.5 Millimeter
Length20 Millimeter
Width5.5 Millimeter
Length20 Millimeter
Width5.5 Millimeter
Length20 Millimeter
Width5.5 Millimeter
Length20 Millimeter
Width5.5 Millimeter
Length20 Millimeter
Width5.5 Millimeter
Length20 Millimeter
Width5.5 Millimeter
Length20 Millimeter
Width5.5 Millimeter
Length20 Millimeter
Width5.5 Millimeter
Length20 Millimeter
Width5.5 Millimeter
Length20 Millimeter
Width5.5 Millimeter
Length20 Millimeter
Width5.5 Millimeter
Length20 Millimeter
Width5.5 Millimeter
Length20 Millimeter
Width5.5 Millimeter
Length20 Millimeter
Width5.5 Millimeter
Length20 Millimeter
Width5.5 Millimeter
Length20 Millimeter
Width5.5 Millimeter
Length20 Millimeter
Width5.5 Millimeter
Length20 Millimeter
Width5.5 Millimeter
Length20 Millimeter
Width5.5 Millimeter
Length20 Millimeter
Width5.5 Millimeter
Length20 Millimeter
Width5.5 Millimeter
Length20 Millimeter
Width5.5 Millimeter
Length20 Millimeter
Width5.5 Millimeter
Length20 Millimeter
Width5.5 Millimeter
Length20 Millimeter
Width5.5 Millimeter
Length20 Millimeter
Width5.5 Millimeter
Length20 Millimeter
Width5.5 Millimeter
Length20 Millimeter
Width5.5 Millimeter
Length20 Millimeter
Width5.5 Millimeter
Length20 Millimeter
Width5.5 Millimeter
Length20 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100840085217845 [Primary]

FDA Product Code

OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840085217845]

Moist Heat or Steam Sterilization


[00840085217845]

Moist Heat or Steam Sterilization


[00840085217845]

Moist Heat or Steam Sterilization


[00840085217845]

Moist Heat or Steam Sterilization


[00840085217845]

Moist Heat or Steam Sterilization


[00840085217845]

Moist Heat or Steam Sterilization


[00840085217845]

Moist Heat or Steam Sterilization


[00840085217845]

Moist Heat or Steam Sterilization


[00840085217845]

Moist Heat or Steam Sterilization


[00840085217845]

Moist Heat or Steam Sterilization


[00840085217845]

Moist Heat or Steam Sterilization


[00840085217845]

Moist Heat or Steam Sterilization


[00840085217845]

Moist Heat or Steam Sterilization


[00840085217845]

Moist Heat or Steam Sterilization


[00840085217845]

Moist Heat or Steam Sterilization


[00840085217845]

Moist Heat or Steam Sterilization


[00840085217845]

Moist Heat or Steam Sterilization


[00840085217845]

Moist Heat or Steam Sterilization


[00840085217845]

Moist Heat or Steam Sterilization


[00840085217845]

Moist Heat or Steam Sterilization


[00840085217845]

Moist Heat or Steam Sterilization


[00840085217845]

Moist Heat or Steam Sterilization


[00840085217845]

Moist Heat or Steam Sterilization


[00840085217845]

Moist Heat or Steam Sterilization


[00840085217845]

Moist Heat or Steam Sterilization


[00840085217845]

Moist Heat or Steam Sterilization


[00840085217845]

Moist Heat or Steam Sterilization


[00840085217845]

Moist Heat or Steam Sterilization


[00840085217845]

Moist Heat or Steam Sterilization


[00840085217845]

Moist Heat or Steam Sterilization


[00840085217845]

Moist Heat or Steam Sterilization


[00840085217845]

Moist Heat or Steam Sterilization


[00840085217845]

Moist Heat or Steam Sterilization


[00840085217845]

Moist Heat or Steam Sterilization


[00840085217845]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-08-11
Device Publish Date2021-08-03

Devices Manufactured by HYHTE HOLDINGS, INC.

00840085265105 - NA2024-04-19 CORTICAL CANCELLOUS CANNULATED SCREW
00840085265112 - NA2024-04-19 CORTICAL CANCELLOUS CANNULATED SCREW
00840085265129 - NA2024-04-19 CORTICAL CANCELLOUS CANNULATED SCREW
00840085265136 - NA2024-04-19 CORTICAL CANCELLOUS CANNULATED SCREW
00840085265143 - NA2024-04-19 CORTICAL CANCELLOUS CANNULATED SCREW
00840085265150 - NA2024-04-19 CORTICAL CANCELLOUS CANNULATED SCREW
00840085257469 - NA2024-04-18 DUAL LEAD SCREW
00840085257476 - NA2024-04-18 DUAL LEAD SCREW

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