FEGA60R04

GUDID 00841379154884

ROD EXTENSION, RIGHT SIDE LOADING

HYHTE HOLDINGS, INC.

Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable Orthopaedic bone pin, non-bioabsorbable
Primary Device ID00841379154884
NIH Device Record Key17c22971-6243-4515-9490-e2908f85a7f1
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberFEGA60R04
Catalog NumberFEGA60R04
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

Device Dimensions

Width4 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter6 Millimeter
Length120 Millimeter
Width4 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter6 Millimeter
Length120 Millimeter
Width4 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter6 Millimeter
Length120 Millimeter
Width4 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter6 Millimeter
Length120 Millimeter
Width4 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter6 Millimeter
Length120 Millimeter
Width4 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter6 Millimeter
Length120 Millimeter
Width4 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter6 Millimeter
Length120 Millimeter
Width4 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter6 Millimeter
Length120 Millimeter
Width4 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter6 Millimeter
Length120 Millimeter
Width4 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter6 Millimeter
Length120 Millimeter
Width4 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter6 Millimeter
Length120 Millimeter
Width4 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter6 Millimeter
Length120 Millimeter
Width4 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter6 Millimeter
Length120 Millimeter
Width4 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter6 Millimeter
Length120 Millimeter
Width4 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter6 Millimeter
Length120 Millimeter
Width4 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter6 Millimeter
Length120 Millimeter
Width4 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter6 Millimeter
Length120 Millimeter
Width4 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter6 Millimeter
Length120 Millimeter
Width4 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter6 Millimeter
Length120 Millimeter
Width4 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter6 Millimeter
Length120 Millimeter
Width4 Millimeter
Outer Diameter5.5 Millimeter
Outer Diameter6 Millimeter
Length120 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100841379154884 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKGPosterior Cervical Screw System

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841379154884]

Moist Heat or Steam Sterilization

[00841379154884]

Moist Heat or Steam Sterilization

[00841379154884]

Moist Heat or Steam Sterilization

[00841379154884]

Moist Heat or Steam Sterilization

[00841379154884]

Moist Heat or Steam Sterilization

[00841379154884]

Moist Heat or Steam Sterilization

[00841379154884]

Moist Heat or Steam Sterilization

[00841379154884]

Moist Heat or Steam Sterilization

[00841379154884]

Moist Heat or Steam Sterilization

[00841379154884]

Moist Heat or Steam Sterilization

[00841379154884]

Moist Heat or Steam Sterilization

[00841379154884]

Moist Heat or Steam Sterilization

[00841379154884]

Moist Heat or Steam Sterilization

[00841379154884]

Moist Heat or Steam Sterilization

[00841379154884]

Moist Heat or Steam Sterilization

[00841379154884]

Moist Heat or Steam Sterilization

[00841379154884]

Moist Heat or Steam Sterilization

[00841379154884]

Moist Heat or Steam Sterilization

[00841379154884]

Moist Heat or Steam Sterilization

[00841379154884]

Moist Heat or Steam Sterilization

[00841379154884]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-08-02
Device Publish Date2021-07-23

Devices Manufactured by HYHTE HOLDINGS, INC.

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00840085265518 - NA2024-04-25 CORTICAL CANCELLOUS CANNULATED SCREW
00840085265525 - NA2024-04-25 CORTICAL CANCELLOUS CANNULATED SCREW
00840085265532 - NA2024-04-25 CORTICAL CANCELLOUS CANNULATED SCREW
00840085265549 - NA2024-04-25 CORTICAL CANCELLOUS CANNULATED SCREW
00840085265556 - NA2024-04-25 CORTICAL CANCELLOUS CANNULATED SCREW
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