PHOENIX

GUDID 18257200116201

Straight Rod with Hex anodized, 600mm

ORTHOFIX INC.

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID18257200116201
NIH Device Record Keyef381c97-5b93-4643-bb7e-3481780f5d85
Commercial Distribution StatusIn Commercial Distribution
Brand NamePHOENIX
Version Model Number20-5600
Company DUNS927083808
Company NameORTHOFIX INC.
Device Count1
DM Exempttrue
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

Phone+1(214)937-3199
Emailosi-customerservice@orthofix.c
Phone+1(214)937-3199
Emailosi-customerservice@orthofix.c
Phone+1(214)937-3199
Emailosi-customerservice@orthofix.com
Phone+1(214)937-3199
Emailosi-customerservice@orthofix.com
Phone+1(214)937-3199
Emailosi-customerservice@orthofix.com
Phone+1(214)937-3199
Emailosi-customerservice@orthofix.com
Phone+1(214)937-3199
Emailosi-customerservice@orthofix.com
Phone+1(214)937-3199
Emailosi-customerservice@orthofix.com
Phone+1(214)937-3199
Emailosi-customerservice@orthofix.com
Phone+1(214)937-3199
Emailosi-customerservice@orthofix.com
Phone+1(214)937-3199
Emailosi-customerservice@orthofix.com
Phone+1(214)937-3199
Emailosi-customerservice@orthofix.com
Phone+1(214)937-3199
Emailosi-customerservice@orthofix.com
Phone+1(214)937-3199
Emailosi-customerservice@orthofix.com
Phone+1(214)937-3199
Emailosi-customerservice@orthofix.com
Phone+1(214)937-3199
Emailosi-customerservice@orthofix.com
Phone+1(214)937-3199
Emailosi-customerservice@orthofix.com
Phone+1(214)937-3199
Emailosi-customerservice@orthofix.com

Device Dimensions

Length600 Millimeter
Length600 Millimeter
Length600 Millimeter
Length600 Millimeter
Length600 Millimeter
Length600 Millimeter
Length600 Millimeter
Length600 Millimeter
Length600 Millimeter
Length600 Millimeter
Length600 Millimeter
Length600 Millimeter
Length600 Millimeter
Length600 Millimeter
Length600 Millimeter
Length600 Millimeter
Length600 Millimeter
Length600 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS118257200116201 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKBOrthosis, spinal pedicle fixation, for degenerative disc disease

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[18257200116201]

Moist Heat or Steam Sterilization


[18257200116201]

Moist Heat or Steam Sterilization


[18257200116201]

Moist Heat or Steam Sterilization


[18257200116201]

Moist Heat or Steam Sterilization


[18257200116201]

Moist Heat or Steam Sterilization


[18257200116201]

Moist Heat or Steam Sterilization


[18257200116201]

Moist Heat or Steam Sterilization


[18257200116201]

Moist Heat or Steam Sterilization


[18257200116201]

Moist Heat or Steam Sterilization


[18257200116201]

Moist Heat or Steam Sterilization


[18257200116201]

Moist Heat or Steam Sterilization


[18257200116201]

Moist Heat or Steam Sterilization


[18257200116201]

Moist Heat or Steam Sterilization


[18257200116201]

Moist Heat or Steam Sterilization


[18257200116201]

Moist Heat or Steam Sterilization


[18257200116201]

Moist Heat or Steam Sterilization


[18257200116201]

Moist Heat or Steam Sterilization


[18257200116201]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-03-14

On-Brand Devices [PHOENIX]

18257200116218Straight Rod w/Hex anodized, 800mm
18257200116201Straight Rod with Hex anodized, 600mm
18257200116195Straight Rod with Hex anodized, 450mm
18257200116188Straight Rod with Hex and Taper anodized, 200mm
18257200116171Straight Rod with Hex and Taper anodized, 180mm
18257200116164Straight Rod with Hex and Taper anodized, 160mm
18257200116157Straight Rod with Hex and Taper anodized, 140mm
18257200116140Straight Rod with Hex and Taper anodized, 120mm
18257200116133Straight Rod with Hex and Taper anodized, 110mm
18257200116126Straight Rod with Hex and Taper anodized, 100mm
18257200116119Straight Rod with Hex and Taper anodized, 90mm
18257200116102Straight Rod with Hex and Taper anodized, 80mm
18257200116096Straight Rod with Hex and Taper anodized, 70mm
18257200116089Straight Rod with Hex and Taper anodized, 60mm
18257200116072Straight Rod with Hex and Taper anodized, 50mm
18257200116065Straight Rod with Hex and Taper anodized, 40mm
18257200116058Pre-Lordosed Rod with Hex and Taper, 200mm
18257200116041Pre-Lordosed Rod with Hex and Taper anodized, 150mm
18257200116034Pre-Lordosed Rod with Hex and Taper anodized, 140mm
18257200116027Pre-Lordosed Rod with Hex and Taper anodized, 130mm
18257200116010Pre-Lordosed Rod with Hex and Taper anodized, 120mm
18257200116003Pre-Lordosed Rod with Hex and Taper anodized, 110mm
18257200115990Pre-Lordosed Rod with Hex and Taper anodized, 100mm
18257200115983Pre-Lordosed Rod with Hex and Taper anodized, 90mm
18257200115976Pre-Lordosed Rod with Hex and Taper anodized, 80mm
18257200115969Pre-Lordosed Rod with Hex and Taper anodized, 75mm
18257200115952Pre-Lordosed Rod with Hex and Taper anodized, 70mm
18257200115945Pre-Lordosed Rod with Hex and Taper anodized, 65mm
18257200115938Pre-Lordosed Rod with Hex and Taper anodized, 60mm
18257200115921Pre-Lordosed Rod with Hex and Taper anodized, 55mm
18257200115914Pre-Lordosed Rod with Hex and Taper anodized, 50mm
18257200115907Pre-Lordosed Rod with Hex and Taper anodized, 45mm
18257200115891Pre-Lordosed Rod with Hex and Taper anodized, 40mm
18257200115884Pre-Lordosed Rod with Hex and Taper anodized, 35mm
18257200080229Pre-Lordosed Rod with Hex and Taper, 200mm
18257200029808CoCr Straight Rod w/Hex, 800mm
18257200029792CoCr Straight Rod w/Hex, 600mm
18257200029785CoCr Straight Rod w/Hex, 450mm
18257200029778CoCr Straight Rod w/Hex and Taper, 200mm
18257200029761CoCr Straight Rod w/Hex and Taper, 180mm
18257200029754CoCr Straight Rod w/Hex and Taper, 160mm
18257200029747CoCr Straight Rod w/Hex and Taper, 140mm
18257200029730CoCr Straight Rod w/Hex and Taper, 120mm
18257200029723CoCr Straight Rod w/Hex and Taper, 110mm
18257200029716CoCr Straight Rod w/Hex and Taper, 100mm
18257200029709CoCr Straight Rod w/Hex and Taper, 90mm
18257200029693CoCr Straight Rod w/Hex and Taper, 80mm
18257200029686CoCr Straight Rod w/Hex and Taper, 70mm
18257200029679CoCr Straight Rod w/Hex and Taper, 60mm
18257200029662CoCr Straight Rod w/Hex and Taper, 50mm

Trademark Results [PHOENIX]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PHOENIX
PHOENIX
98761513 not registered Live/Pending
Seelochan, Mathew
2024-09-20
PHOENIX
PHOENIX
98722228 not registered Live/Pending
Kevin Ding
2024-08-28
PHOENIX
PHOENIX
98718766 not registered Live/Pending
Phoenix Oil Tools International, LLC
2024-08-27
PHOENIX
PHOENIX
98683421 not registered Live/Pending
Tavus Inc.
2024-08-05
PHOENIX
PHOENIX
98581009 not registered Live/Pending
Phoenix Group Management Services Limited
2024-06-03
PHOENIX
PHOENIX
98562667 not registered Live/Pending
ICON Technology, Inc.
2024-05-22
PHOENIX
PHOENIX
98558728 not registered Live/Pending
PHOENIX Retail LLC
2024-05-20
PHOENIX
PHOENIX
98558721 not registered Live/Pending
PHOENIX Retail LLC
2024-05-20
PHOENIX
PHOENIX
98496598 not registered Live/Pending
Paragon Motorcycles Inc.
2024-04-12
PHOENIX
PHOENIX
98375788 not registered Live/Pending
JTM Products, Inc.
2024-01-25
PHOENIX
PHOENIX
98372020 not registered Live/Pending
Winpak Lane, Inc.
2024-01-23
PHOENIX
PHOENIX
98355373 not registered Live/Pending
ProSep Ltd
2024-01-12

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.