AAMA75030

GUDID 00841379120766

HIGH TOP LARGE DIAMETER POLYAXIAL SCREW, CANNULATED

HYHTE HOLDINGS, INC.

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00841379120766
NIH Device Record Key6bf63d74-8c36-4832-b11a-596d9417ddcd
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberAAMA75030
Catalog NumberAAMA75030
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
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 Diameter7.5 Millimeter
Length30 Millimeter
Outer Diameter7.5 Millimeter
Length30 Millimeter
Outer Diameter7.5 Millimeter
Length30 Millimeter
Outer Diameter7.5 Millimeter
Length30 Millimeter
Outer Diameter7.5 Millimeter
Length30 Millimeter
Outer Diameter7.5 Millimeter
Length30 Millimeter
Outer Diameter7.5 Millimeter
Length30 Millimeter
Outer Diameter7.5 Millimeter
Length30 Millimeter
Outer Diameter7.5 Millimeter
Length30 Millimeter
Outer Diameter7.5 Millimeter
Length30 Millimeter
Outer Diameter7.5 Millimeter
Length30 Millimeter
Outer Diameter7.5 Millimeter
Length30 Millimeter
Outer Diameter7.5 Millimeter
Length30 Millimeter
Outer Diameter7.5 Millimeter
Length30 Millimeter
Outer Diameter7.5 Millimeter
Length30 Millimeter
Outer Diameter7.5 Millimeter
Length30 Millimeter
Outer Diameter7.5 Millimeter
Length30 Millimeter
Outer Diameter7.5 Millimeter
Length30 Millimeter
Outer Diameter7.5 Millimeter
Length30 Millimeter
Outer Diameter7.5 Millimeter
Length30 Millimeter
Outer Diameter7.5 Millimeter
Length30 Millimeter
Outer Diameter7.5 Millimeter
Length30 Millimeter
Outer Diameter7.5 Millimeter
Length30 Millimeter
Outer Diameter7.5 Millimeter
Length30 Millimeter
Outer Diameter7.5 Millimeter
Length30 Millimeter
Outer Diameter7.5 Millimeter
Length30 Millimeter
Outer Diameter7.5 Millimeter
Length30 Millimeter
Outer Diameter7.5 Millimeter
Length30 Millimeter
Outer Diameter7.5 Millimeter
Length30 Millimeter
Outer Diameter7.5 Millimeter
Length30 Millimeter
Outer Diameter7.5 Millimeter
Length30 Millimeter
Outer Diameter7.5 Millimeter
Length30 Millimeter
Outer Diameter7.5 Millimeter
Length30 Millimeter
Outer Diameter7.5 Millimeter
Length30 Millimeter
Outer Diameter7.5 Millimeter
Length30 Millimeter
Outer Diameter7.5 Millimeter
Length30 Millimeter
Outer Diameter7.5 Millimeter
Length30 Millimeter
Outer Diameter7.5 Millimeter
Length30 Millimeter
Outer Diameter7.5 Millimeter
Length30 Millimeter
Outer Diameter7.5 Millimeter
Length30 Millimeter
Outer Diameter7.5 Millimeter
Length30 Millimeter
Outer Diameter7.5 Millimeter
Length30 Millimeter
Outer Diameter7.5 Millimeter
Length30 Millimeter
Outer Diameter7.5 Millimeter
Length30 Millimeter
Outer Diameter7.5 Millimeter
Length30 Millimeter
Outer Diameter7.5 Millimeter
Length30 Millimeter
Outer Diameter7.5 Millimeter
Length30 Millimeter
Outer Diameter7.5 Millimeter
Length30 Millimeter
Outer Diameter7.5 Millimeter
Length30 Millimeter
Outer Diameter7.5 Millimeter
Length30 Millimeter
Outer Diameter7.5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100841379120766 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MNIOrthosis, Spinal Pedicle Fixation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841379120766]

Moist Heat or Steam Sterilization

[00841379120766]

Moist Heat or Steam Sterilization

[00841379120766]

Moist Heat or Steam Sterilization

[00841379120766]

Moist Heat or Steam Sterilization

[00841379120766]

Moist Heat or Steam Sterilization

[00841379120766]

Moist Heat or Steam Sterilization

[00841379120766]

Moist Heat or Steam Sterilization

[00841379120766]

Moist Heat or Steam Sterilization

[00841379120766]

Moist Heat or Steam Sterilization

[00841379120766]

Moist Heat or Steam Sterilization

[00841379120766]

Moist Heat or Steam Sterilization

[00841379120766]

Moist Heat or Steam Sterilization

[00841379120766]

Moist Heat or Steam Sterilization

[00841379120766]

Moist Heat or Steam Sterilization

[00841379120766]

Moist Heat or Steam Sterilization

[00841379120766]

Moist Heat or Steam Sterilization

[00841379120766]

Moist Heat or Steam Sterilization

[00841379120766]

Moist Heat or Steam Sterilization

[00841379120766]

Moist Heat or Steam Sterilization

[00841379120766]

Moist Heat or Steam Sterilization

[00841379120766]

Moist Heat or Steam Sterilization

[00841379120766]

Moist Heat or Steam Sterilization

[00841379120766]

Moist Heat or Steam Sterilization

[00841379120766]

Moist Heat or Steam Sterilization

[00841379120766]

Moist Heat or Steam Sterilization

[00841379120766]

Moist Heat or Steam Sterilization

[00841379120766]

Moist Heat or Steam Sterilization

[00841379120766]

Moist Heat or Steam Sterilization

[00841379120766]

Moist Heat or Steam Sterilization

[00841379120766]

Moist Heat or Steam Sterilization

[00841379120766]

Moist Heat or Steam Sterilization

[00841379120766]

Moist Heat or Steam Sterilization

[00841379120766]

Moist Heat or Steam Sterilization

[00841379120766]

Moist Heat or Steam Sterilization

[00841379120766]

Moist Heat or Steam Sterilization

[00841379120766]

Moist Heat or Steam Sterilization

[00841379120766]

Moist Heat or Steam Sterilization

[00841379120766]

Moist Heat or Steam Sterilization

[00841379120766]

Moist Heat or Steam Sterilization

[00841379120766]

Moist Heat or Steam Sterilization

[00841379120766]

Moist Heat or Steam Sterilization

[00841379120766]

Moist Heat or Steam Sterilization

[00841379120766]

Moist Heat or Steam Sterilization

[00841379120766]

Moist Heat or Steam Sterilization

[00841379120766]

Moist Heat or Steam Sterilization

[00841379120766]

Moist Heat or Steam Sterilization

[00841379120766]

Moist Heat or Steam Sterilization

[00841379120766]

Moist Heat or Steam Sterilization

[00841379120766]

Moist Heat or Steam Sterilization

[00841379120766]

Moist Heat or Steam Sterilization

[00841379120766]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number2
Public Version Date2018-07-06
Device Publish Date2018-04-30

Devices Manufactured by HYHTE HOLDINGS, INC.

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00840085273322 - NA2024-11-06 ENDPLATE, 16MM, VARIABLE LORDOSIS, LATERAL, FULL, L.
00840085273339 - NA2024-11-06 ENDPLATE, 16MM, VARIABLE LORDOSIS, LATERAL, FULL, L.
00840085273346 - NA2024-11-06 ENDPLATE, 16MM, VARIABLE LORDOSIS, LATERAL, FULL, L.
00840085273353 - NA2024-11-06 ENDPLATE, 16MM, VARIABLE LORDOSIS, LATERAL, FULL, L.
00840085273360 - NA2024-11-06 ENDPLATE, 16MM, VARIABLE LORDOSIS, LATERAL, FULL, L.
00840085273377 - NA2024-11-06 ENDPLATE, 16MM, VARIABLE LORDOSIS, LATERAL, FULL, L.
00840085273384 - NA2024-11-06 ENDPLATE, 16MM, VARIABLE LORDOSIS, LATERAL, FULL, L.
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