AJKA75080

GUDID 00841379174240

LRG DIA POLYAXIAL SCREW, CANN, EXT TAB, SELF CUTTING,

HYHTE HOLDINGS, INC.

Spinal bone screw, non-bioabsorbable
Primary Device ID00841379174240
NIH Device Record Keyf26b51d4-0701-4d6d-95f0-7d8059cc75c0
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberAJKA75080
Catalog NumberAJKA75080
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 Diameter7.5 Millimeter
Length80 Millimeter
Outer Diameter7.5 Millimeter
Length80 Millimeter
Outer Diameter7.5 Millimeter
Length80 Millimeter
Outer Diameter7.5 Millimeter
Length80 Millimeter
Outer Diameter7.5 Millimeter
Length80 Millimeter
Outer Diameter7.5 Millimeter
Length80 Millimeter
Outer Diameter7.5 Millimeter
Length80 Millimeter
Outer Diameter7.5 Millimeter
Length80 Millimeter
Outer Diameter7.5 Millimeter
Length80 Millimeter
Outer Diameter7.5 Millimeter
Length80 Millimeter
Outer Diameter7.5 Millimeter
Length80 Millimeter
Outer Diameter7.5 Millimeter
Length80 Millimeter
Outer Diameter7.5 Millimeter
Length80 Millimeter
Outer Diameter7.5 Millimeter
Length80 Millimeter
Outer Diameter7.5 Millimeter
Length80 Millimeter
Outer Diameter7.5 Millimeter
Length80 Millimeter
Outer Diameter7.5 Millimeter
Length80 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100841379174240 [Primary]

FDA Product Code

NKBThoracolumbosacral Pedicle Screw System

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841379174240]

Moist Heat or Steam Sterilization

[00841379174240]

Moist Heat or Steam Sterilization

[00841379174240]

Moist Heat or Steam Sterilization

[00841379174240]

Moist Heat or Steam Sterilization

[00841379174240]

Moist Heat or Steam Sterilization

[00841379174240]

Moist Heat or Steam Sterilization

[00841379174240]

Moist Heat or Steam Sterilization

[00841379174240]

Moist Heat or Steam Sterilization

[00841379174240]

Moist Heat or Steam Sterilization

[00841379174240]

Moist Heat or Steam Sterilization

[00841379174240]

Moist Heat or Steam Sterilization

[00841379174240]

Moist Heat or Steam Sterilization

[00841379174240]

Moist Heat or Steam Sterilization

[00841379174240]

Moist Heat or Steam Sterilization

[00841379174240]

Moist Heat or Steam Sterilization

[00841379174240]

Moist Heat or Steam Sterilization

[00841379174240]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2024-11-06
Device Publish Date2021-05-28

Devices Manufactured by HYHTE HOLDINGS, INC.

00840085244940 - NA2025-01-31 RATCHETING AXIAL HANDLE 2.0 , 1/4 SQ, MIS STYLET ATTACHMENT BACK CAP
00840085244957 - NA2025-01-31 FAVORED ANGLE C/C, EXTENDED TAB (MIS), EXTENDED THREAD, TULIP
00840085244964 - NA2025-01-31 FAVORED ANGLE C/C, EXTENDED TAB (MIS), EXTENDED THREAD, TULIP
00840085272257 - NA2025-01-31 MIS SCREW DRIVER, T27
00840085272493 - NA2025-01-31 TULIP INSERTER, AXIAL, EXT. TAB
00840085274541 - NA2025-01-31 TULIP UNLOCKER, EXT. TAB
00840085274596 - NA2025-01-31 NAVIGATED SCREW DRIVER, MIS T27
00840085274671 - NA2025-01-31 MIS TOWER SCREW DRIVER, T27
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