Phoenix SFS

GUDID 18257200080236

Mono Axial Open Body Short

ORTHOFIX INC.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 18257200080236
• NIH Device Record Key: c64ada7c-813c-4df9-b21f-9ade52aa7e20
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Phoenix SFS
• Version Model Number: 20-8070
• Company DUNS: 927083808
• Company Name: ORTHOFIX INC.
• 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: true
• 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(214)9373199
• Email: osi-customerservice@orthofix.c
• Phone: +1(214)9373199
• Email: osi-customerservice@orthofix.c
• Phone: +1(214)9373199
• Email: osi-customerservice@orthofix.com
• Phone: +1(214)9373199
• Email: osi-customerservice@orthofix.com
• Phone: +1(214)9373199
• Email: osi-customerservice@orthofix.com
• Phone: +1(214)9373199
• Email: osi-customerservice@orthofix.com
• Phone: +1(214)9373199
• Email: osi-customerservice@orthofix.com
• Phone: +1(214)9373199
• Email: osi-customerservice@orthofix.com
• Phone: +1(214)9373199
• Email: osi-customerservice@orthofix.com
• Phone: +1(214)9373199
• Email: osi-customerservice@orthofix.com
• Phone: +1(214)9373199
• Email: osi-customerservice@orthofix.com
• Phone: +1(214)9373199
• Email: osi-customerservice@orthofix.com
• Phone: +1(214)9373199
• Email: osi-customerservice@orthofix.com
• Phone: +1(214)9373199
• Email: osi-customerservice@orthofix.com
• Phone: +1(214)9373199
• Email: osi-customerservice@orthofix.com
• Phone: +1(214)9373199
• Email: osi-customerservice@orthofix.com
• Phone: +1(214)9373199
• Email: osi-customerservice@orthofix.com
• Phone: +1(214)9373199
• Email: osi-customerservice@orthofix.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	18257200080236 [Primary]

FDA Product Code

• NKB: Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease

Sterilization

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

[18257200080236]

Moist Heat or Steam Sterilization

[18257200080236]

Moist Heat or Steam Sterilization

[18257200080236]

Moist Heat or Steam Sterilization

[18257200080236]

Moist Heat or Steam Sterilization

[18257200080236]

Moist Heat or Steam Sterilization

[18257200080236]

Moist Heat or Steam Sterilization

[18257200080236]

Moist Heat or Steam Sterilization

[18257200080236]

Moist Heat or Steam Sterilization

[18257200080236]

Moist Heat or Steam Sterilization

[18257200080236]

Moist Heat or Steam Sterilization

[18257200080236]

Moist Heat or Steam Sterilization

[18257200080236]

Moist Heat or Steam Sterilization

[18257200080236]

Moist Heat or Steam Sterilization

[18257200080236]

Moist Heat or Steam Sterilization

[18257200080236]

Moist Heat or Steam Sterilization

[18257200080236]

Moist Heat or Steam Sterilization

[18257200080236]

Moist Heat or Steam Sterilization

[18257200080236]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-03-14

On-Brand Devices [Phoenix SFS]

• 18257200134434: 9.5MM CANULATED JANUS TAP
• 18257200134427: 8.5MM CANULATED JANUS TAP
• 18257200134410: 7.5MM CANULATED JANUS TAP
• 18257200134403: 6.5MM CANULATED JANUS TAP
• 18257200134397: 5.5MM CANULATED JANUS TAP
• 18257200134380: 4.5MM CANULATED JANUS TAP
• 18257200133574: GUIDE WIRE, NITINOL, 21", SHARP, THREADED
• 18257200125814: BONE MARROW ASPIRATION NEEDLE, 11 GAGE, 8" LENGTH
• 18257200125784: BONE MARROW ASPIRATION NEEDLE, 8 GAGE, 6" LENGTH
• 18257200117505: LID, PHOENIX, IMPLANT CASE
• 18257200117499: BOTTOM TRAY, PHOENIX, IMPLANT CASE
• 18257200117482: BASE, PHOENIX, IMPLANT CASE
• 18257200117475: LID, PHOENIX, INSTRUMENT CASE 2
• 18257200117468: BASE, PHOENIX, INSTRUMENT CASE 2
• 18257200117451: SCREW BODY CADDY 2ND TRAY, STD/SHORT, PHOENIX, IMPLANT CASE
• 18257200117086: SET SCREW CADDY, PHOENIX, IMPLANT CASE
• 18257200117079: GUIDE WIRE, SHARP, PHOENIX, INSTRUMENT CASE
• 18257200117062: GUIDEWIRE, BLUNT, PHOENIX, INSTRUMENT CASE
• 18257200117055: 90-7337, SCREW BODY CADDY, TALL, PHOENIX, IMPLANT CASE
• 18257200117048: SCREW BODY CADDY, STD/SHORT, PHOENIX, IMPLANT CASE
• 18257200117031: LID, PHOENIX, IMPLANT CASE
• 18257200117024: TOP TRAY, PHOENIX, IMPLANT CASE
• 18257200117017: BOTTOM TRAY, PHOENIX, IMPLANT CASE
• 18257200117000: BASE, PHOENIX, IMPLANT CASE
• 18257200116997: LID, PHOENIX, INSTRUMENT CASE
• 18257200116980: TOP TRAY, PHOENIX, INSTRUMENT CASE
• 18257200116973: BOTTOM TRAY, PHOENIX, INSTRUMENT CASE
• 18257200093663: PHOENIX COMPRESSION/DISTRACTION TRAY KIT (20-0030)
• 18257200087594: ROD INSERTER, PHOENIX MIS SYSTEM
• 18257200084388: FAST DRIVE
• 18257200082179: PHOENIX (XRS) IMPLANTS CASE (20-0017)
• 18257200080250: Mono Axial Open Body Tall
• 18257200080243: Mono Axial Open Body Standard
• 18257200080236: Mono Axial Open Body Short
• 18257200080212: 90MM OFFET COMPRESSOR/DISTRACTOR TIP
• 18257200080205: 60MM OFFET COMPRESSOR/DISTRACTOR TIP
• 18257200080199: 30MM OFFET COMPRESSOR/DISTRACTOR TIP
• 18257200080182: STRAIGHT COMPRESSOR/DISTRACTOR TIP
• 18257200080175: DISTRACTOR
• 18257200080168: COMPRESSOR
• 18257200080151: SET SCREW DRIVER
• 18257200080144: DVR TOWER - TALL
• 18257200080137: DVR TOWER - STANDARD
• 18257200080090: MIS COUNTER-TORQUE TOWER
• 18257200080083: COMPRESSION-DISTRACTION FIXTURE
• 18257200080076: ROD INSERTER DRIVER
• 18257200080052: HANDLE ADAPTER
• 18257200080045: MONO-AXIAL SCREW DRIVER, PHOENIX
• 18257200080038: 10.5/11.5MM CANNULATED TAP SLEEVE ASSY
• 18257200080021: 8.5/9.5MM CANNULATED TAP SLEEVE ASSY