BB093211A

GUDID 00841379101130

OTLIF SPACER

HYHTE HOLDINGS, INC.

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Primary Device ID00841379101130
NIH Device Record Keyccec5afa-cce9-4a4c-aa29-06643e3e9130
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberBB093211A
Catalog NumberBB093211A
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
Phone7608148047
EmailPARKER@ASTURAMEDICAL.COM
Phone7608148047
EmailPARKER@ASTURAMEDICAL.COM

Device Dimensions

Angle0 degree
Width9 Millimeter
Length32 Millimeter
Height11 Millimeter
Angle0 degree
Width9 Millimeter
Length32 Millimeter
Height11 Millimeter
Angle0 degree
Width9 Millimeter
Length32 Millimeter
Height11 Millimeter
Angle0 degree
Width9 Millimeter
Length32 Millimeter
Height11 Millimeter
Angle0 degree
Width9 Millimeter
Length32 Millimeter
Height11 Millimeter
Angle0 degree
Width9 Millimeter
Length32 Millimeter
Height11 Millimeter
Angle0 degree
Width9 Millimeter
Length32 Millimeter
Height11 Millimeter
Angle0 degree
Width9 Millimeter
Length32 Millimeter
Height11 Millimeter
Angle0 degree
Width9 Millimeter
Length32 Millimeter
Height11 Millimeter
Angle0 degree
Width9 Millimeter
Length32 Millimeter
Height11 Millimeter
Angle0 degree
Width9 Millimeter
Length32 Millimeter
Height11 Millimeter
Angle0 degree
Width9 Millimeter
Length32 Millimeter
Height11 Millimeter
Angle0 degree
Width9 Millimeter
Length32 Millimeter
Height11 Millimeter
Angle0 degree
Width9 Millimeter
Length32 Millimeter
Height11 Millimeter
Angle0 degree
Width9 Millimeter
Length32 Millimeter
Height11 Millimeter
Angle0 degree
Width9 Millimeter
Length32 Millimeter
Height11 Millimeter
Angle0 degree

Device Identifiers

Device Issuing AgencyDevice ID
GS100841379101130 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841379101130]

Moist Heat or Steam Sterilization


[00841379101130]

Moist Heat or Steam Sterilization


[00841379101130]

Moist Heat or Steam Sterilization


[00841379101130]

Moist Heat or Steam Sterilization


[00841379101130]

Moist Heat or Steam Sterilization


[00841379101130]

Moist Heat or Steam Sterilization


[00841379101130]

Moist Heat or Steam Sterilization


[00841379101130]

Moist Heat or Steam Sterilization


[00841379101130]

Moist Heat or Steam Sterilization


[00841379101130]

Moist Heat or Steam Sterilization


[00841379101130]

Moist Heat or Steam Sterilization


[00841379101130]

Moist Heat or Steam Sterilization


[00841379101130]

Moist Heat or Steam Sterilization


[00841379101130]

Moist Heat or Steam Sterilization


[00841379101130]

Moist Heat or Steam Sterilization


[00841379101130]

Moist Heat or Steam Sterilization


[00841379101130]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-02-24
Device Publish Date2018-02-15

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00840085262739 - NA2024-02-23 SI SCREW TAP, STANDARD, Ø8MM
00840085262746 - NA2024-02-23 SI SCREW TAP, STANDARD, Ø10MM
00840085262753 - NA2024-02-23 SI SCREW TAP, STANDARD, Ø12MM
00840085262760 - NA2024-02-23 SI SCREW TAP, STANDARD, Ø14MM

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