CBBB45012

GUDID 00841379103318

ACS, SELF TAPPING, VARIABLE, 4.5MM-12MM

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 Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable
Primary Device ID00841379103318
NIH Device Record Key3819d8dc-e7a1-45ba-bf1e-cc802d053f06
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberCBBB45012
Catalog NumberCBBB45012
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
Phone7608148047
EmailTROY@ASTURAMEDICAL.COM
Phone7608148047
EmailTROY@ASTURAMEDICAL.COM

Device Dimensions

Length12 Millimeter
Outer Diameter4.5 Millimeter
Length12 Millimeter
Outer Diameter4.5 Millimeter
Length12 Millimeter
Outer Diameter4.5 Millimeter
Length12 Millimeter
Outer Diameter4.5 Millimeter
Length12 Millimeter
Outer Diameter4.5 Millimeter
Length12 Millimeter
Outer Diameter4.5 Millimeter
Length12 Millimeter
Outer Diameter4.5 Millimeter
Length12 Millimeter
Outer Diameter4.5 Millimeter
Length12 Millimeter
Outer Diameter4.5 Millimeter
Length12 Millimeter
Outer Diameter4.5 Millimeter
Length12 Millimeter
Outer Diameter4.5 Millimeter
Length12 Millimeter
Outer Diameter4.5 Millimeter
Length12 Millimeter
Outer Diameter4.5 Millimeter
Length12 Millimeter
Outer Diameter4.5 Millimeter
Length12 Millimeter
Outer Diameter4.5 Millimeter
Length12 Millimeter
Outer Diameter4.5 Millimeter
Length12 Millimeter
Outer Diameter4.5 Millimeter
Length12 Millimeter
Outer Diameter4.5 Millimeter
Length12 Millimeter
Outer Diameter4.5 Millimeter
Length12 Millimeter
Outer Diameter4.5 Millimeter
Length12 Millimeter
Outer Diameter4.5 Millimeter
Length12 Millimeter
Outer Diameter4.5 Millimeter
Length12 Millimeter
Outer Diameter4.5 Millimeter
Length12 Millimeter
Outer Diameter4.5 Millimeter
Length12 Millimeter
Outer Diameter4.5 Millimeter
Length12 Millimeter
Outer Diameter4.5 Millimeter
Length12 Millimeter
Outer Diameter4.5 Millimeter
Length12 Millimeter
Outer Diameter4.5 Millimeter
Length12 Millimeter
Outer Diameter4.5 Millimeter
Length12 Millimeter
Outer Diameter4.5 Millimeter
Length12 Millimeter
Outer Diameter4.5 Millimeter
Length12 Millimeter
Outer Diameter4.5 Millimeter
Length12 Millimeter
Outer Diameter4.5 Millimeter
Length12 Millimeter
Outer Diameter4.5 Millimeter
Length12 Millimeter
Outer Diameter4.5 Millimeter
Length12 Millimeter
Outer Diameter4.5 Millimeter
Length12 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100841379103318 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAppliance, Fixation, Spinal Intervertebral Body

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841379103318]

Moist Heat or Steam Sterilization

[00841379103318]

Moist Heat or Steam Sterilization

[00841379103318]

Moist Heat or Steam Sterilization

[00841379103318]

Moist Heat or Steam Sterilization

[00841379103318]

Moist Heat or Steam Sterilization

[00841379103318]

Moist Heat or Steam Sterilization

[00841379103318]

Moist Heat or Steam Sterilization

[00841379103318]

Moist Heat or Steam Sterilization

[00841379103318]

Moist Heat or Steam Sterilization

[00841379103318]

Moist Heat or Steam Sterilization

[00841379103318]

Moist Heat or Steam Sterilization

[00841379103318]

Moist Heat or Steam Sterilization

[00841379103318]

Moist Heat or Steam Sterilization

[00841379103318]

Moist Heat or Steam Sterilization

[00841379103318]

Moist Heat or Steam Sterilization

[00841379103318]

Moist Heat or Steam Sterilization

[00841379103318]

Moist Heat or Steam Sterilization

[00841379103318]

Moist Heat or Steam Sterilization

[00841379103318]

Moist Heat or Steam Sterilization

[00841379103318]

Moist Heat or Steam Sterilization

[00841379103318]

Moist Heat or Steam Sterilization

[00841379103318]

Moist Heat or Steam Sterilization

[00841379103318]

Moist Heat or Steam Sterilization

[00841379103318]

Moist Heat or Steam Sterilization

[00841379103318]

Moist Heat or Steam Sterilization

[00841379103318]

Moist Heat or Steam Sterilization

[00841379103318]

Moist Heat or Steam Sterilization

[00841379103318]

Moist Heat or Steam Sterilization

[00841379103318]

Moist Heat or Steam Sterilization

[00841379103318]

Moist Heat or Steam Sterilization

[00841379103318]

Moist Heat or Steam Sterilization

[00841379103318]

Moist Heat or Steam Sterilization

[00841379103318]

Moist Heat or Steam Sterilization

[00841379103318]

Moist Heat or Steam Sterilization

[00841379103318]

Moist Heat or Steam Sterilization

[00841379103318]

Moist Heat or Steam Sterilization

[00841379103318]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-04-09
Device Publish Date2016-09-02

Devices Manufactured by HYHTE HOLDINGS, INC.

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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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