AFGARNMS0

GUDID 00841379159407

RAMPED OFFSET LAMINA HOOK, MEDIUM,NARROW, RIGHT

HYHTE HOLDINGS, INC.

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00841379159407
NIH Device Record Key8ba6a85c-d88d-45f0-a8d6-4f74efc2ecd4
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberAFGARNMS0
Catalog NumberAFGARNMS0
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

Device Dimensions

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Device Identifiers

Device Issuing AgencyDevice ID
GS100841379159407 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKBThoracolumbosacral Pedicle Screw System

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841379159407]

Microwave Radiation

[00841379159407]

Microwave Radiation

[00841379159407]

Microwave Radiation

[00841379159407]

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[00841379159407]

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[00841379159407]

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Microwave Radiation

[00841379159407]

Microwave Radiation

[00841379159407]

Microwave Radiation

[00841379159407]

Microwave Radiation

[00841379159407]

Microwave Radiation

[00841379159407]

Microwave Radiation

[00841379159407]

Microwave Radiation

[00841379159407]

Microwave Radiation

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-09-17
Device Publish Date2018-08-16

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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