AASA85045

GUDID 00841379124696

LARGE DIAMETER POLYAXIAL SCREW

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 ID00841379124696
NIH Device Record Key0fefbf50-81c0-45be-848d-e793083cf3d7
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberAASA85045
Catalog NumberAASA85045
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 Diameter8.5 Millimeter
Length45 Millimeter
Outer Diameter8.5 Millimeter
Length45 Millimeter
Outer Diameter8.5 Millimeter
Length45 Millimeter
Outer Diameter8.5 Millimeter
Length45 Millimeter
Outer Diameter8.5 Millimeter
Length45 Millimeter
Outer Diameter8.5 Millimeter
Length45 Millimeter
Outer Diameter8.5 Millimeter
Length45 Millimeter
Outer Diameter8.5 Millimeter
Length45 Millimeter
Outer Diameter8.5 Millimeter
Length45 Millimeter
Outer Diameter8.5 Millimeter
Length45 Millimeter
Outer Diameter8.5 Millimeter
Length45 Millimeter
Outer Diameter8.5 Millimeter
Length45 Millimeter
Outer Diameter8.5 Millimeter
Length45 Millimeter
Outer Diameter8.5 Millimeter
Length45 Millimeter
Outer Diameter8.5 Millimeter
Length45 Millimeter
Outer Diameter8.5 Millimeter
Length45 Millimeter
Outer Diameter8.5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100841379124696 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MNHOrthosis, Spondylolisthesis Spinal Fixation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841379124696]

Moist Heat or Steam Sterilization

[00841379124696]

Moist Heat or Steam Sterilization

[00841379124696]

Moist Heat or Steam Sterilization

[00841379124696]

Moist Heat or Steam Sterilization

[00841379124696]

Moist Heat or Steam Sterilization

[00841379124696]

Moist Heat or Steam Sterilization

[00841379124696]

Moist Heat or Steam Sterilization

[00841379124696]

Moist Heat or Steam Sterilization

[00841379124696]

Moist Heat or Steam Sterilization

[00841379124696]

Moist Heat or Steam Sterilization

[00841379124696]

Moist Heat or Steam Sterilization

[00841379124696]

Moist Heat or Steam Sterilization

[00841379124696]

Moist Heat or Steam Sterilization

[00841379124696]

Moist Heat or Steam Sterilization

[00841379124696]

Moist Heat or Steam Sterilization

[00841379124696]

Moist Heat or Steam Sterilization

[00841379124696]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number2
Public Version Date2018-07-06
Device Publish Date2018-05-07

Devices Manufactured by HYHTE HOLDINGS, INC.

00840085254413 - NA2024-05-07 POLYAXIAL, TULIP
00840085254420 - NA2024-05-07 POLYAXIAL, HIGH TOP, TULIP
00840085254437 - NA2024-05-07 POLYAXIAL, EXTENDED TAB, TULIP
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
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.