KJA13200C

GUDID 00840085248375

OBLIQUE ALIF PLATE, ZERO

HYHTE HOLDINGS, INC.

Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage
Primary Device ID00840085248375
NIH Device Record Key489a0eb9-47d4-408b-92ad-4a7036f0ce8a
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberKJA13200C
Catalog NumberKJA13200C
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

Device Dimensions

Height13 Millimeter
Angle20 degree
Height13 Millimeter
Angle20 degree
Height13 Millimeter
Angle20 degree
Height13 Millimeter
Angle20 degree
Height13 Millimeter
Angle20 degree
Height13 Millimeter
Angle20 degree
Height13 Millimeter
Angle20 degree
Height13 Millimeter
Angle20 degree
Height13 Millimeter
Angle20 degree
Height13 Millimeter
Angle20 degree
Height13 Millimeter
Angle20 degree
Height13 Millimeter
Angle20 degree

Device Identifiers

Device Issuing AgencyDevice ID
GS100840085248375 [Primary]

FDA Product Code

OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840085248375]

Moist Heat or Steam Sterilization


[00840085248375]

Moist Heat or Steam Sterilization


[00840085248375]

Moist Heat or Steam Sterilization


[00840085248375]

Moist Heat or Steam Sterilization


[00840085248375]

Moist Heat or Steam Sterilization


[00840085248375]

Moist Heat or Steam Sterilization


[00840085248375]

Moist Heat or Steam Sterilization


[00840085248375]

Moist Heat or Steam Sterilization


[00840085248375]

Moist Heat or Steam Sterilization


[00840085248375]

Moist Heat or Steam Sterilization


[00840085248375]

Moist Heat or Steam Sterilization


[00840085248375]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-05-16
Device Publish Date2022-05-06

Devices Manufactured by HYHTE HOLDINGS, INC.

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00840085254741 - NA2024-04-15 DUAL LEAD SCREW
00840085254758 - NA2024-04-15 DUAL LEAD SCREW
00840085254765 - NA2024-04-15 DUAL LEAD SCREW

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