AEBA60030

GUDID 00841379136545

LATERAL ROD CONNECTOR, TOP LOADING

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 ID00841379136545
NIH Device Record Key0c83ebf1-b7bd-4a63-a807-18e262109110
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberAEBA60030
Catalog NumberAEBA60030
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
EmailTROY@ASTURAMEDICAL.COM
Phone7608148047
EmailTROY@ASTURAMEDICAL.COM
Phone7608148047
EmailTROY@ASTURAMEDICAL.COM
Phone7608148047
EmailTROY@ASTURAMEDICAL.COM
Phone7608148047
EmailTROY@ASTURAMEDICAL.COM
Phone7608148047
EmailTROY@ASTURAMEDICAL.COM
Phone7608148047
EmailTROY@ASTURAMEDICAL.COM
Phone7608148047
EmailTROY@ASTURAMEDICAL.COM
Phone7608148047
EmailTROY@ASTURAMEDICAL.COM
Phone7608148047
EmailTROY@ASTURAMEDICAL.COM
Phone7608148047
EmailTROY@ASTURAMEDICAL.COM
Phone7608148047
EmailTROY@ASTURAMEDICAL.COM
Phone7608148047
EmailTROY@ASTURAMEDICAL.COM
Phone7608148047
EmailTROY@ASTURAMEDICAL.COM
Phone7608148047
EmailTROY@ASTURAMEDICAL.COM
Phone7608148047
EmailTROY@ASTURAMEDICAL.COM
Phone7608148047
EmailTROY@ASTURAMEDICAL.COM

Device Dimensions

Lumen/Inner Diameter6 Millimeter
Length30 Millimeter
Lumen/Inner Diameter6 Millimeter
Length30 Millimeter
Lumen/Inner Diameter6 Millimeter
Length30 Millimeter
Lumen/Inner Diameter6 Millimeter
Length30 Millimeter
Lumen/Inner Diameter6 Millimeter
Length30 Millimeter
Lumen/Inner Diameter6 Millimeter
Length30 Millimeter
Lumen/Inner Diameter6 Millimeter
Length30 Millimeter
Lumen/Inner Diameter6 Millimeter
Length30 Millimeter
Lumen/Inner Diameter6 Millimeter
Length30 Millimeter
Lumen/Inner Diameter6 Millimeter
Length30 Millimeter
Lumen/Inner Diameter6 Millimeter
Length30 Millimeter
Lumen/Inner Diameter6 Millimeter
Length30 Millimeter
Lumen/Inner Diameter6 Millimeter
Length30 Millimeter
Lumen/Inner Diameter6 Millimeter
Length30 Millimeter
Lumen/Inner Diameter6 Millimeter
Length30 Millimeter
Lumen/Inner Diameter6 Millimeter
Length30 Millimeter
Lumen/Inner Diameter6 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100841379136545 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MNHOrthosis, Spondylolisthesis Spinal Fixation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841379136545]

Moist Heat or Steam Sterilization

[00841379136545]

Moist Heat or Steam Sterilization

[00841379136545]

Moist Heat or Steam Sterilization

[00841379136545]

Moist Heat or Steam Sterilization

[00841379136545]

Moist Heat or Steam Sterilization

[00841379136545]

Moist Heat or Steam Sterilization

[00841379136545]

Moist Heat or Steam Sterilization

[00841379136545]

Moist Heat or Steam Sterilization

[00841379136545]

Moist Heat or Steam Sterilization

[00841379136545]

Moist Heat or Steam Sterilization

[00841379136545]

Moist Heat or Steam Sterilization

[00841379136545]

Moist Heat or Steam Sterilization

[00841379136545]

Moist Heat or Steam Sterilization

[00841379136545]

Moist Heat or Steam Sterilization

[00841379136545]

Moist Heat or Steam Sterilization

[00841379136545]

Moist Heat or Steam Sterilization

[00841379136545]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-23

Devices Manufactured by HYHTE HOLDINGS, INC.

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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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