AAQA40055

GUDID 00841379123149

CORTICAL MONOAXIAL 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 ID00841379123149
NIH Device Record Keyb9e0c723-f56e-4b13-8bb0-6f5125234b41
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberAAQA40055
Catalog NumberAAQA40055
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

Outer Diameter4 Millimeter
Length55 Millimeter
Outer Diameter4 Millimeter
Length55 Millimeter
Outer Diameter4 Millimeter
Length55 Millimeter
Outer Diameter4 Millimeter
Length55 Millimeter
Outer Diameter4 Millimeter
Length55 Millimeter
Outer Diameter4 Millimeter
Length55 Millimeter
Outer Diameter4 Millimeter
Length55 Millimeter
Outer Diameter4 Millimeter
Length55 Millimeter
Outer Diameter4 Millimeter
Length55 Millimeter
Outer Diameter4 Millimeter
Length55 Millimeter
Outer Diameter4 Millimeter
Length55 Millimeter
Outer Diameter4 Millimeter
Length55 Millimeter
Outer Diameter4 Millimeter
Length55 Millimeter
Outer Diameter4 Millimeter
Length55 Millimeter
Outer Diameter4 Millimeter
Length55 Millimeter
Outer Diameter4 Millimeter
Length55 Millimeter
Outer Diameter4 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100841379123149 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MNIOrthosis, Spinal Pedicle Fixation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841379123149]

Moist Heat or Steam Sterilization


[00841379123149]

Moist Heat or Steam Sterilization


[00841379123149]

Moist Heat or Steam Sterilization


[00841379123149]

Moist Heat or Steam Sterilization


[00841379123149]

Moist Heat or Steam Sterilization


[00841379123149]

Moist Heat or Steam Sterilization


[00841379123149]

Moist Heat or Steam Sterilization


[00841379123149]

Moist Heat or Steam Sterilization


[00841379123149]

Moist Heat or Steam Sterilization


[00841379123149]

Moist Heat or Steam Sterilization


[00841379123149]

Moist Heat or Steam Sterilization


[00841379123149]

Moist Heat or Steam Sterilization


[00841379123149]

Moist Heat or Steam Sterilization


[00841379123149]

Moist Heat or Steam Sterilization


[00841379123149]

Moist Heat or Steam Sterilization


[00841379123149]

Moist Heat or Steam Sterilization


[00841379123149]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number2
Public Version Date2018-07-06
Device Publish Date2018-05-02

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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