KJB19000E

GUDID 00840085248757

OBLIQUE ALIF PLATE, LS-RI HALF

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 ID00840085248757
NIH Device Record Key3c05838e-bd06-4233-b81b-3a075cea3190
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberKJB19000E
Catalog NumberKJB19000E
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

Height19 Millimeter
Angle30 degree
Height19 Millimeter
Angle30 degree
Height19 Millimeter
Angle30 degree
Height19 Millimeter
Angle30 degree
Height19 Millimeter
Angle30 degree
Height19 Millimeter
Angle30 degree
Height19 Millimeter
Angle30 degree
Height19 Millimeter
Angle30 degree
Height19 Millimeter
Angle30 degree
Height19 Millimeter
Angle30 degree
Height19 Millimeter
Angle30 degree
Height19 Millimeter
Angle30 degree

Device Identifiers

Device Issuing AgencyDevice ID
GS100840085248757 [Primary]

FDA Product Code

OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840085248757]

Moist Heat or Steam Sterilization

[00840085248757]

Moist Heat or Steam Sterilization

[00840085248757]

Moist Heat or Steam Sterilization

[00840085248757]

Moist Heat or Steam Sterilization

[00840085248757]

Moist Heat or Steam Sterilization

[00840085248757]

Moist Heat or Steam Sterilization

[00840085248757]

Moist Heat or Steam Sterilization

[00840085248757]

Moist Heat or Steam Sterilization

[00840085248757]

Moist Heat or Steam Sterilization

[00840085248757]

Moist Heat or Steam Sterilization

[00840085248757]

Moist Heat or Steam Sterilization

[00840085248757]

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.

00840085254413 - NA2024-05-07 POLYAXIAL, TULIP
00840085254420 - NA2024-05-07 POLYAXIAL, HIGH TOP, TULIP
00840085254437 - NA2024-05-07 POLYAXIAL, EXTENDED TAB, TULIP
00840085254444 - NA2024-05-07 FAVORED ANGLE M/L, TULIP
00840085254451 - NA2024-05-07 FAVORED ANGLE M/L, HIGH TOP, TULIP
00840085254468 - NA2024-05-07 FAVORED ANGLE M/L, EXTENED TAB, TULIP
00840085254475 - NA2024-05-07 FAVORED ANGLE C/C, TULIP
00840085254482 - NA2024-05-07 FAVORED ANGLE C/C, HIGH TOP, TULIP
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