AACA00110

GUDID 00841379113249

MONOAXIAL SCREW

HYHTE HOLDINGS, INC.

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00841379113249
NIH Device Record Key7ef7a418-35a8-424e-b475-6fb56adacf5e
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberAACA00110
Catalog NumberAACA00110
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
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

Outer Diameter10 Millimeter
Length110 Millimeter
Outer Diameter10 Millimeter
Length110 Millimeter
Outer Diameter10 Millimeter
Length110 Millimeter
Outer Diameter10 Millimeter
Length110 Millimeter
Outer Diameter10 Millimeter
Length110 Millimeter
Outer Diameter10 Millimeter
Length110 Millimeter
Outer Diameter10 Millimeter
Length110 Millimeter
Outer Diameter10 Millimeter
Length110 Millimeter
Outer Diameter10 Millimeter
Length110 Millimeter
Outer Diameter10 Millimeter
Length110 Millimeter
Outer Diameter10 Millimeter
Length110 Millimeter
Outer Diameter10 Millimeter
Length110 Millimeter
Outer Diameter10 Millimeter
Length110 Millimeter
Outer Diameter10 Millimeter
Length110 Millimeter
Outer Diameter10 Millimeter
Length110 Millimeter
Outer Diameter10 Millimeter
Length110 Millimeter
Outer Diameter10 Millimeter
Length110 Millimeter
Outer Diameter10 Millimeter
Length110 Millimeter
Outer Diameter10 Millimeter
Length110 Millimeter
Outer Diameter10 Millimeter
Length110 Millimeter
Outer Diameter10 Millimeter
Length110 Millimeter
Outer Diameter10 Millimeter
Length110 Millimeter
Outer Diameter10 Millimeter
Length110 Millimeter
Outer Diameter10 Millimeter
Length110 Millimeter
Outer Diameter10 Millimeter
Length110 Millimeter
Outer Diameter10 Millimeter
Length110 Millimeter
Outer Diameter10 Millimeter
Length110 Millimeter
Outer Diameter10 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100841379113249 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MNHOrthosis, Spondylolisthesis Spinal Fixation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841379113249]

Moist Heat or Steam Sterilization

[00841379113249]

Moist Heat or Steam Sterilization

[00841379113249]

Moist Heat or Steam Sterilization

[00841379113249]

Moist Heat or Steam Sterilization

[00841379113249]

Moist Heat or Steam Sterilization

[00841379113249]

Moist Heat or Steam Sterilization

[00841379113249]

Moist Heat or Steam Sterilization

[00841379113249]

Moist Heat or Steam Sterilization

[00841379113249]

Moist Heat or Steam Sterilization

[00841379113249]

Moist Heat or Steam Sterilization

[00841379113249]

Moist Heat or Steam Sterilization

[00841379113249]

Moist Heat or Steam Sterilization

[00841379113249]

Moist Heat or Steam Sterilization

[00841379113249]

Moist Heat or Steam Sterilization

[00841379113249]

Moist Heat or Steam Sterilization

[00841379113249]

Moist Heat or Steam Sterilization

[00841379113249]

Moist Heat or Steam Sterilization

[00841379113249]

Moist Heat or Steam Sterilization

[00841379113249]

Moist Heat or Steam Sterilization

[00841379113249]

Moist Heat or Steam Sterilization

[00841379113249]

Moist Heat or Steam Sterilization

[00841379113249]

Moist Heat or Steam Sterilization

[00841379113249]

Moist Heat or Steam Sterilization

[00841379113249]

Moist Heat or Steam Sterilization

[00841379113249]

Moist Heat or Steam Sterilization

[00841379113249]

Moist Heat or Steam Sterilization

[00841379113249]

Moist Heat or Steam Sterilization

[00841379113249]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number2
Public Version Date2018-07-06
Device Publish Date2018-04-11

Devices Manufactured by HYHTE HOLDINGS, INC.

00840085271861 - NA2025-03-06 EGPS, LUMBAR PEDICLE AWL
00840085271878 - NA2025-03-06 EGPS, LUMBAR PEDICLE PROBE, STRAIGHT
00840085271885 - NA2025-03-06 EGPS, LUMBAR PEDICLE PROBE, CURVED
00840085271892 - NA2025-03-06 EGPS, THORACIC PEDICLE PROBE, STRAIGHT
00840085271908 - NA2025-03-06 EGPS, THORACIC PEDICLE PROBE, CURVED
00840085271915 - NA2025-03-06 EGPS, REAMING PILOT DRILL, 3.5MM
00840085271922 - NA2025-03-06 EGPS, CORTICAL, TAP, 3.5MM
00840085271939 - NA2025-03-06 EGPS, CORTICAL, TAP, 4.0MM
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.