RC1001280

GUDID 00840085269189

SI SCREW, FIXED, COMPRESSION THREAD, ASTURACOAT FINISH

HYHTE HOLDINGS, INC.

Spinal bone screw, non-bioabsorbable
Primary Device ID00840085269189
NIH Device Record Key940f3ae2-1b76-4a0c-a8cd-052158cd994c
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberRC1001280
Catalog NumberRC1001280
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

Length80 Millimeter
Outer Diameter12 Millimeter
Length80 Millimeter
Outer Diameter12 Millimeter
Length80 Millimeter
Outer Diameter12 Millimeter
Length80 Millimeter
Outer Diameter12 Millimeter
Length80 Millimeter
Outer Diameter12 Millimeter
Length80 Millimeter
Outer Diameter12 Millimeter
Length80 Millimeter
Outer Diameter12 Millimeter
Length80 Millimeter
Outer Diameter12 Millimeter
Length80 Millimeter
Outer Diameter12 Millimeter
Length80 Millimeter
Outer Diameter12 Millimeter
Length80 Millimeter
Outer Diameter12 Millimeter
Length80 Millimeter
Outer Diameter12 Millimeter
Length80 Millimeter
Outer Diameter12 Millimeter
Length80 Millimeter
Outer Diameter12 Millimeter
Length80 Millimeter
Outer Diameter12 Millimeter
Length80 Millimeter
Outer Diameter12 Millimeter
Length80 Millimeter
Outer Diameter12 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100840085269189 [Primary]

FDA Product Code

MNHOrthosis, Spondylolisthesis Spinal Fixation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840085269189]

Moist Heat or Steam Sterilization

[00840085269189]

Moist Heat or Steam Sterilization

[00840085269189]

Moist Heat or Steam Sterilization

[00840085269189]

Moist Heat or Steam Sterilization

[00840085269189]

Moist Heat or Steam Sterilization

[00840085269189]

Moist Heat or Steam Sterilization

[00840085269189]

Moist Heat or Steam Sterilization

[00840085269189]

Moist Heat or Steam Sterilization

[00840085269189]

Moist Heat or Steam Sterilization

[00840085269189]

Moist Heat or Steam Sterilization

[00840085269189]

Moist Heat or Steam Sterilization

[00840085269189]

Moist Heat or Steam Sterilization

[00840085269189]

Moist Heat or Steam Sterilization

[00840085269189]

Moist Heat or Steam Sterilization

[00840085269189]

Moist Heat or Steam Sterilization

[00840085269189]

Moist Heat or Steam Sterilization

[00840085269189]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2024-11-05
Device Publish Date2024-02-13

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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