AABA70110

GUDID 00841379109730

POLYAXIAL SCREW, CANNULATED

HYHTE HOLDINGS, INC.

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00841379109730
NIH Device Record Key66d90c82-09ba-4d28-8a82-19df351a3e83
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberAABA70110
Catalog NumberAABA70110
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

Device Dimensions

Length110 Millimeter
Outer Diameter7 Millimeter
Length110 Millimeter
Outer Diameter7 Millimeter
Length110 Millimeter
Outer Diameter7 Millimeter
Length110 Millimeter
Outer Diameter7 Millimeter
Length110 Millimeter
Outer Diameter7 Millimeter
Length110 Millimeter
Outer Diameter7 Millimeter
Length110 Millimeter
Outer Diameter7 Millimeter
Length110 Millimeter
Outer Diameter7 Millimeter
Length110 Millimeter
Outer Diameter7 Millimeter
Length110 Millimeter
Outer Diameter7 Millimeter
Length110 Millimeter
Outer Diameter7 Millimeter
Length110 Millimeter
Outer Diameter7 Millimeter
Length110 Millimeter
Outer Diameter7 Millimeter
Length110 Millimeter
Outer Diameter7 Millimeter
Length110 Millimeter
Outer Diameter7 Millimeter
Length110 Millimeter
Outer Diameter7 Millimeter
Length110 Millimeter
Outer Diameter7 Millimeter
Length110 Millimeter
Outer Diameter7 Millimeter
Length110 Millimeter
Outer Diameter7 Millimeter
Length110 Millimeter
Outer Diameter7 Millimeter
Length110 Millimeter
Outer Diameter7 Millimeter
Length110 Millimeter
Outer Diameter7 Millimeter
Length110 Millimeter
Outer Diameter7 Millimeter
Length110 Millimeter
Outer Diameter7 Millimeter
Length110 Millimeter
Outer Diameter7 Millimeter
Length110 Millimeter
Outer Diameter7 Millimeter
Length110 Millimeter
Outer Diameter7 Millimeter
Length110 Millimeter
Outer Diameter7 Millimeter
Length110 Millimeter
Outer Diameter7 Millimeter
Length110 Millimeter
Outer Diameter7 Millimeter
Length110 Millimeter
Outer Diameter7 Millimeter
Length110 Millimeter
Outer Diameter7 Millimeter
Length110 Millimeter
Outer Diameter7 Millimeter
Length110 Millimeter
Outer Diameter7 Millimeter
Length110 Millimeter
Outer Diameter7 Millimeter
Length110 Millimeter
Outer Diameter7 Millimeter
Length110 Millimeter
Outer Diameter7 Millimeter
Length110 Millimeter
Outer Diameter7 Millimeter
Length110 Millimeter
Outer Diameter7 Millimeter
Length110 Millimeter
Outer Diameter7 Millimeter
Length110 Millimeter
Outer Diameter7 Millimeter
Length110 Millimeter
Outer Diameter7 Millimeter
Length110 Millimeter
Outer Diameter7 Millimeter
Length110 Millimeter
Outer Diameter7 Millimeter
Length110 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100841379109730 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OSHPedicle Screw Spinal System, Adolescent Idiopathic Scoliosis

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841379109730]

Moist Heat or Steam Sterilization

[00841379109730]

Moist Heat or Steam Sterilization

[00841379109730]

Moist Heat or Steam Sterilization

[00841379109730]

Moist Heat or Steam Sterilization

[00841379109730]

Moist Heat or Steam Sterilization

[00841379109730]

Moist Heat or Steam Sterilization

[00841379109730]

Moist Heat or Steam Sterilization

[00841379109730]

Moist Heat or Steam Sterilization

[00841379109730]

Moist Heat or Steam Sterilization

[00841379109730]

Moist Heat or Steam Sterilization

[00841379109730]

Moist Heat or Steam Sterilization

[00841379109730]

Moist Heat or Steam Sterilization

[00841379109730]

Moist Heat or Steam Sterilization

[00841379109730]

Moist Heat or Steam Sterilization

[00841379109730]

Moist Heat or Steam Sterilization

[00841379109730]

Moist Heat or Steam Sterilization

[00841379109730]

Moist Heat or Steam Sterilization

[00841379109730]

Moist Heat or Steam Sterilization

[00841379109730]

Moist Heat or Steam Sterilization

[00841379109730]

Moist Heat or Steam Sterilization

[00841379109730]

Moist Heat or Steam Sterilization

[00841379109730]

Moist Heat or Steam Sterilization

[00841379109730]

Moist Heat or Steam Sterilization

[00841379109730]

Moist Heat or Steam Sterilization

[00841379109730]

Moist Heat or Steam Sterilization

[00841379109730]

Moist Heat or Steam Sterilization

[00841379109730]

Moist Heat or Steam Sterilization

[00841379109730]

Moist Heat or Steam Sterilization

[00841379109730]

Moist Heat or Steam Sterilization

[00841379109730]

Moist Heat or Steam Sterilization

[00841379109730]

Moist Heat or Steam Sterilization

[00841379109730]

Moist Heat or Steam Sterilization

[00841379109730]

Moist Heat or Steam Sterilization

[00841379109730]

Moist Heat or Steam Sterilization

[00841379109730]

Moist Heat or Steam Sterilization

[00841379109730]

Moist Heat or Steam Sterilization

[00841379109730]

Moist Heat or Steam Sterilization

[00841379109730]

Moist Heat or Steam Sterilization

[00841379109730]

Moist Heat or Steam Sterilization

[00841379109730]

Moist Heat or Steam Sterilization

[00841379109730]

Moist Heat or Steam Sterilization

[00841379109730]

Moist Heat or Steam Sterilization

[00841379109730]

Moist Heat or Steam Sterilization

[00841379109730]

Moist Heat or Steam Sterilization

[00841379109730]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number2
Public Version Date2018-07-06
Device Publish Date2018-03-14

Devices Manufactured by HYHTE HOLDINGS, INC.

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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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