AAAA40020

GUDID 00841379106319

POLYAXIAL SCREW

HYHTE HOLDINGS, INC.

Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00841379106319
NIH Device Record Keyaeeca2c8-7eaa-4ee6-945d-87efd7afffcf
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberAAAA40020
Catalog NumberAAAA40020
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

Device Dimensions

Outer Diameter4 Millimeter
Length20 Millimeter
Outer Diameter4 Millimeter
Length20 Millimeter
Outer Diameter4 Millimeter
Length20 Millimeter
Outer Diameter4 Millimeter
Length20 Millimeter
Outer Diameter4 Millimeter
Length20 Millimeter
Outer Diameter4 Millimeter
Length20 Millimeter
Outer Diameter4 Millimeter
Length20 Millimeter
Outer Diameter4 Millimeter
Length20 Millimeter
Outer Diameter4 Millimeter
Length20 Millimeter
Outer Diameter4 Millimeter
Length20 Millimeter
Outer Diameter4 Millimeter
Length20 Millimeter
Outer Diameter4 Millimeter
Length20 Millimeter
Outer Diameter4 Millimeter
Length20 Millimeter
Outer Diameter4 Millimeter
Length20 Millimeter
Outer Diameter4 Millimeter
Length20 Millimeter
Outer Diameter4 Millimeter
Length20 Millimeter
Outer Diameter4 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100841379106319 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MNHOrthosis, Spondylolisthesis Spinal Fixation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841379106319]

Moist Heat or Steam Sterilization

[00841379106319]

Moist Heat or Steam Sterilization

[00841379106319]

Moist Heat or Steam Sterilization

[00841379106319]

Moist Heat or Steam Sterilization

[00841379106319]

Moist Heat or Steam Sterilization

[00841379106319]

Moist Heat or Steam Sterilization

[00841379106319]

Moist Heat or Steam Sterilization

[00841379106319]

Moist Heat or Steam Sterilization

[00841379106319]

Moist Heat or Steam Sterilization

[00841379106319]

Moist Heat or Steam Sterilization

[00841379106319]

Moist Heat or Steam Sterilization

[00841379106319]

Moist Heat or Steam Sterilization

[00841379106319]

Moist Heat or Steam Sterilization

[00841379106319]

Moist Heat or Steam Sterilization

[00841379106319]

Moist Heat or Steam Sterilization

[00841379106319]

Moist Heat or Steam Sterilization

[00841379106319]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-23

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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