STARFIRE™ Pedicle Screw System

GUDID 00840996125321

STARFIRE,STARTER,SINGLE END,SET SCREW

Choice Spine, LP

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00840996125321
• NIH Device Record Key: 6fad53b0-ad89-4a63-9ceb-f041376f9124
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STARFIRE™ Pedicle Screw System
• Version Model Number: E070-0036
• Company DUNS: 078293017
• Company Name: Choice Spine, LP
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(865)246-3333
• Email: info@choicespine.net

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840996125321 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102204

FDA Product Code

• LXH: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00840996125321]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-02-26

On-Brand Devices [STARFIRE™ Pedicle Screw System]

• 00840996146630: SPCL,STARFIRE,TAP,3.5
• 00840996146623: 1/4 SQ. W/STRYKER DRIVE,SPCL
• 00840996146616: SCREWDRIVER,PUSH PULL,STARFIRE,SPECIAL
• 00840996146609: PED SCREW DRVR,STARFIRE,SPECIAL
• 00840996146593: STARTER,CONNECTOR SCREW
• 00840996146586: DRIVER,CONNECTOR SCREW
• 00840996146579: PROBE,CURVED,DUCKBILL
• 00840996146562: PROBE,STRAIGHT,DUCKBILL
• 00840996146555: STARFIRE,TAP,8.5
• 00840996125710: STARFIRE,AXIAL,NONRATCHET,SQUARE,CANN
• 00840996125703: STARFIRE,KWIRE,TROCAR,1.3X500
• 00840996125697: STARFIRE,PALM HANDLE,RATCHET,CANN,SQUARE
• 00840996125680: STARFIRE,TAP,PEDICLE,8.5
• 00840996125673: STARFIRE,TAP,PEDICLE,7.5
• 00840996125666: STARFIRE,TAP,PEDICLE,6.5
• 00840996125659: STARFIRE,TAP,PEDICLE,5.5
• 00840996125642: STARFIRE,TAP,PEDICLE,4.5
• 00840996125635: STARFIRE,CANN,TAP,8.5
• 00840996125628: STARFIRE,CANN,TAP,7.5
• 00840996125611: STARFIRE,CANN,TAP,6.5
• 00840996125604: STARFIRE,CANN,TAP,5.5
• 00840996125598: STARFIRE,CANN,TAP,4.5
• 00840996125581: STARFIRE,CANN,PEDICLE SCREW DRIVER
• 00840996125574: UNIV,CANN,AWL
• 00840996125543: UNIV,PROBE,STRAIGHT TAPER
• 00840996125536: STARFIRE,REDUCTION COUNTERTORQUE
• 00840996125529: UNIV,PROBE,BALL TIP,CURVED
• 00840996125512: UNIV,ADAPTOR,1/4 SQ DRIVE TO JACOBS
• 00840996125505: STARFIRE,ROD HOLDER
• 00840996125499: STARFIRE,ROD CUTTER
• 00840996125482: UNIV,PROBE,BALL-TIP,90DEG
• 00840996125475: UNIV,PROBE,BALL-TIP,STRAIGHT
• 00840996125468: UNIV,PROBE,BALL-TIP,DUAL,90DEG
• 00840996125451: UNIV,PROBE,CURVED,DUCKBILL
• 00840996125444: UNIV,PROBE,STRAIGHT,DUCKBILL
• 00840996125437: STARFIRE,ROD TEMPLATE,6.0X440
• 00840996125420: STARFIRE,HANDLE,TULIP POSITIONER
• 00840996125413: UNIV,T HANDLE,RATCHET,SQUARE,CANNULATED
• 00840996125406: UNIV,AXIAL,RATCHET,SQUARE,CANNULATED
• 00840996125390: STARFIRE,PERSUADER,T-HANDLE
• 00840996125383: UNIV,T HANDLE,TORQUE,70,SQUARE
• 00840996125376: UNIV,T HANDLE,TORQUE,40,SQUARE
• 00840996125369: STARFIRE,REDUCTION SCREW DRIVER
• 00840996125352: STARFIRE,SCREW LOADING BLOCK
• 00840996125345: UNIV,ROD GRIPPER,6MM
• 00840996125338: STARFIRE,MEASURING DEVICE,CONNECTOR
• 00840996125321: STARFIRE,STARTER,SINGLE END,SET SCREW
• 00840996125314: STARFIRE,TAB BREAKER,REDUCTION SCREW
• 00840996125307: UNIV,T HANDLE,TORQUE,40,SQUARE
• 00840996125291: UNIV,T HANDLE,RATCHET,CANNULATED,SQUARE