STARFIRE™ Pedicle Screw System

GUDID 00840996103251

STARFIRE,SCREW,POLYAXIAL,CANN,7.5X110

Choice Spine, LP

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00840996103251
NIH Device Record Key5b3f1e65-754b-4ae6-983e-106714ca8e0b
Commercial Distribution StatusIn Commercial Distribution
Brand NameSTARFIRE™ Pedicle Screw System
Version Model NumberET10-75110
Company DUNS078293017
Company NameChoice Spine, LP
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

Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net
Phone+1(865)246-3333
Emailinfo@choicespine.net

Device Dimensions

Length110 Millimeter
Outer Diameter7.5 Millimeter
Length110 Millimeter
Outer Diameter7.5 Millimeter
Length110 Millimeter
Outer Diameter7.5 Millimeter
Length110 Millimeter
Outer Diameter7.5 Millimeter
Length110 Millimeter
Outer Diameter7.5 Millimeter
Length110 Millimeter
Outer Diameter7.5 Millimeter
Length110 Millimeter
Outer Diameter7.5 Millimeter
Length110 Millimeter
Outer Diameter7.5 Millimeter
Length110 Millimeter
Outer Diameter7.5 Millimeter
Length110 Millimeter
Outer Diameter7.5 Millimeter
Length110 Millimeter
Outer Diameter7.5 Millimeter
Length110 Millimeter
Outer Diameter7.5 Millimeter
Length110 Millimeter
Outer Diameter7.5 Millimeter
Length110 Millimeter
Outer Diameter7.5 Millimeter
Length110 Millimeter
Outer Diameter7.5 Millimeter
Length110 Millimeter
Outer Diameter7.5 Millimeter
Length110 Millimeter
Outer Diameter7.5 Millimeter
Length110 Millimeter
Outer Diameter7.5 Millimeter
Length110 Millimeter
Outer Diameter7.5 Millimeter
Length110 Millimeter
Outer Diameter7.5 Millimeter
Length110 Millimeter
Outer Diameter7.5 Millimeter
Length110 Millimeter
Outer Diameter7.5 Millimeter
Length110 Millimeter
Outer Diameter7.5 Millimeter
Length110 Millimeter
Outer Diameter7.5 Millimeter
Length110 Millimeter
Outer Diameter7.5 Millimeter
Length110 Millimeter
Outer Diameter7.5 Millimeter
Length110 Millimeter
Outer Diameter7.5 Millimeter
Length110 Millimeter
Outer Diameter7.5 Millimeter
Length110 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100840996103251 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MNHOrthosis, spondylolisthesis spinal fixation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840996103251]

Moist Heat or Steam Sterilization

[00840996103251]

Moist Heat or Steam Sterilization

[00840996103251]

Moist Heat or Steam Sterilization

[00840996103251]

Moist Heat or Steam Sterilization

[00840996103251]

Moist Heat or Steam Sterilization

[00840996103251]

Moist Heat or Steam Sterilization

[00840996103251]

Moist Heat or Steam Sterilization

[00840996103251]

Moist Heat or Steam Sterilization

[00840996103251]

Moist Heat or Steam Sterilization

[00840996103251]

Moist Heat or Steam Sterilization

[00840996103251]

Moist Heat or Steam Sterilization

[00840996103251]

Moist Heat or Steam Sterilization

[00840996103251]

Moist Heat or Steam Sterilization

[00840996103251]

Moist Heat or Steam Sterilization

[00840996103251]

Moist Heat or Steam Sterilization

[00840996103251]

Moist Heat or Steam Sterilization

[00840996103251]

Moist Heat or Steam Sterilization

[00840996103251]

Moist Heat or Steam Sterilization

[00840996103251]

Moist Heat or Steam Sterilization

[00840996103251]

Moist Heat or Steam Sterilization

[00840996103251]

Moist Heat or Steam Sterilization

[00840996103251]

Moist Heat or Steam Sterilization

[00840996103251]

Moist Heat or Steam Sterilization

[00840996103251]

Moist Heat or Steam Sterilization

[00840996103251]

Moist Heat or Steam Sterilization

[00840996103251]

Moist Heat or Steam Sterilization

[00840996103251]

Moist Heat or Steam Sterilization

[00840996103251]

Moist Heat or Steam Sterilization

[00840996103251]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-10-24

On-Brand Devices [STARFIRE™ Pedicle Screw System]

00840996146630SPCL,STARFIRE,TAP,3.5
008409961466231/4 SQ. W/STRYKER DRIVE,SPCL
00840996146616SCREWDRIVER,PUSH PULL,STARFIRE,SPECIAL
00840996146609PED SCREW DRVR,STARFIRE,SPECIAL
00840996146593STARTER,CONNECTOR SCREW
00840996146586DRIVER,CONNECTOR SCREW
00840996146579PROBE,CURVED,DUCKBILL
00840996146562PROBE,STRAIGHT,DUCKBILL
00840996146555STARFIRE,TAP,8.5
00840996125710STARFIRE,AXIAL,NONRATCHET,SQUARE,CANN
00840996125703STARFIRE,KWIRE,TROCAR,1.3X500
00840996125697STARFIRE,PALM HANDLE,RATCHET,CANN,SQUARE
00840996125680STARFIRE,TAP,PEDICLE,8.5
00840996125673STARFIRE,TAP,PEDICLE,7.5
00840996125666STARFIRE,TAP,PEDICLE,6.5
00840996125659STARFIRE,TAP,PEDICLE,5.5
00840996125642STARFIRE,TAP,PEDICLE,4.5
00840996125635STARFIRE,CANN,TAP,8.5
00840996125628STARFIRE,CANN,TAP,7.5
00840996125611STARFIRE,CANN,TAP,6.5
00840996125604STARFIRE,CANN,TAP,5.5
00840996125598STARFIRE,CANN,TAP,4.5
00840996125581STARFIRE,CANN,PEDICLE SCREW DRIVER
00840996125574UNIV,CANN,AWL
00840996125543UNIV,PROBE,STRAIGHT TAPER
00840996125536STARFIRE,REDUCTION COUNTERTORQUE
00840996125529UNIV,PROBE,BALL TIP,CURVED
00840996125512UNIV,ADAPTOR,1/4 SQ DRIVE TO JACOBS
00840996125505STARFIRE,ROD HOLDER
00840996125499STARFIRE,ROD CUTTER
00840996125482UNIV,PROBE,BALL-TIP,90DEG
00840996125475UNIV,PROBE,BALL-TIP,STRAIGHT
00840996125468UNIV,PROBE,BALL-TIP,DUAL,90DEG
00840996125451UNIV,PROBE,CURVED,DUCKBILL
00840996125444UNIV,PROBE,STRAIGHT,DUCKBILL
00840996125437STARFIRE,ROD TEMPLATE,6.0X440
00840996125420STARFIRE,HANDLE,TULIP POSITIONER
00840996125413UNIV,T HANDLE,RATCHET,SQUARE,CANNULATED
00840996125406UNIV,AXIAL,RATCHET,SQUARE,CANNULATED
00840996125390STARFIRE,PERSUADER,T-HANDLE
00840996125383UNIV,T HANDLE,TORQUE,70,SQUARE
00840996125376UNIV,T HANDLE,TORQUE,40,SQUARE
00840996125369STARFIRE,REDUCTION SCREW DRIVER
00840996125352STARFIRE,SCREW LOADING BLOCK
00840996125345UNIV,ROD GRIPPER,6MM
00840996125338STARFIRE,MEASURING DEVICE,CONNECTOR
00840996125321STARFIRE,STARTER,SINGLE END,SET SCREW
00840996125314STARFIRE,TAB BREAKER,REDUCTION SCREW
00840996125307UNIV,T HANDLE,TORQUE,40,SQUARE
00840996125291UNIV,T HANDLE,RATCHET,CANNULATED,SQUARE

Trademark Results [STARFIRE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
STARFIRE
STARFIRE
98782183 not registered Live/Pending
Starfire Enterprises, L.L.C.
2024-10-02
STARFIRE
STARFIRE
98191427 not registered Live/Pending
Jody Cloud
2023-09-21
STARFIRE
STARFIRE
97524578 not registered Live/Pending
PPG INDUSTRIES OHIO, INC.
2022-07-28
STARFIRE
STARFIRE
97199701 not registered Live/Pending
Gel Blaster, LLC
2022-01-01
STARFIRE
STARFIRE
90580307 not registered Live/Pending
Sequoia T. Starre LLC
2021-03-15
STARFIRE
STARFIRE
90073851 not registered Live/Pending
ESSENE COMMUNITY LIFE CHURCH
2020-07-26
STARFIRE
STARFIRE
88830387 not registered Live/Pending
Vitro Flat Glass LLC
2020-03-11
STARFIRE
STARFIRE
87768132 5513819 Live/Registered
Coolants Plus, Inc.
2018-01-24
STARFIRE
STARFIRE
87768123 5513817 Live/Registered
Coolants Plus, Inc.
2018-01-24
STARFIRE
STARFIRE
87745994 not registered Live/Pending
Raffles Investments (Proprietary) Limited
2018-01-06
STARFIRE
STARFIRE
87427127 5563538 Live/Registered
STARFIRE HOLDINGS LTD.
2017-04-26
STARFIRE
STARFIRE
87384431 5358661 Live/Registered
Coolants Plus, Inc.
2017-03-24
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.