SFS;SFS LE;SFS SCOLI

GUDID 18257200056668

4.5MM X 60MM MULTI-AXIAL SCREW SELF TAPPING

ORTHOFIX INC.

Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 18257200056668
• NIH Device Record Key: 1dcf823e-cc81-4147-8f26-9fdd4baf9ad9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SFS;SFS LE;SFS SCOLI
• Version Model Number: 58-3460
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com
• Phone: +1(800)527-0404
• Email: customerservice@orthofix.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	18257200056668 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080407

FDA Product Code

• MNI: Orthosis, spinal pedicle fixation

Sterilization

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

[18257200056668]

Moist Heat or Steam Sterilization

[18257200056668]

Moist Heat or Steam Sterilization

[18257200056668]

Moist Heat or Steam Sterilization

[18257200056668]

Moist Heat or Steam Sterilization

[18257200056668]

Moist Heat or Steam Sterilization

[18257200056668]

Moist Heat or Steam Sterilization

[18257200056668]

Moist Heat or Steam Sterilization

[18257200056668]

Moist Heat or Steam Sterilization

[18257200056668]

Moist Heat or Steam Sterilization

[18257200056668]

Moist Heat or Steam Sterilization

[18257200056668]

Moist Heat or Steam Sterilization

[18257200056668]

Moist Heat or Steam Sterilization

[18257200056668]

Moist Heat or Steam Sterilization

[18257200056668]

Moist Heat or Steam Sterilization

[18257200056668]

Moist Heat or Steam Sterilization

[18257200056668]

Moist Heat or Steam Sterilization

[18257200056668]

Moist Heat or Steam Sterilization

[18257200056668]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-03-27
• Device Publish Date: 2019-03-19

On-Brand Devices [SFS;SFS LE;SFS SCOLI]

• 18257200058723: 8.5X80 MONO-AXIAL REDUCTION PEDICLE SCREW
• 18257200058716: 8.5X75 MONO-AXIAL REDUCTION PEDICLE SCREW
• 18257200058709: 8.5X70 MONO-AXIAL REDUCTION PEDICLE SCREW
• 18257200058693: 8.5X65 MONO-AXIAL REDUCTION PEDICLE SCREW
• 18257200058686: 8.5X60 MONO-AXIAL REDUCTION PEDICLE SCREW
• 18257200058679: 8.5X55 MONO-AXIAL REDUCTION PEDICLE SCREW
• 18257200058662: 8.5X50 MONO-AXIAL REDUCTION PEDICLE SCREW
• 18257200058655: 8.5X45 MONO-AXIAL REDUCTION PEDICLE SCREW
• 18257200058648: 8.5X40 MONO-AXIAL REDUCTION PEDICLE SCREW
• 18257200058631: 8.5X35 MONO-AXIAL REDUCTION PEDICLE SCREW
• 18257200058624: 8.5X30 MONO-AXIAL REDUCTION PEDICLE SCREW
• 18257200058617: 8.5X25 MONO-AXIAL REDUCTION PEDICLE SCREW
• 18257200058600: 7.5X80 MONO-AXIAL REDUCTION PEDICLE SCREW
• 18257200058594: 7.5X75 MONO-AXIAL REDUCTION PEDICLE SCREW
• 18257200058587: 7.5X70 MONO-AXIAL REDUCTION PEDICLE SCREW
• 18257200058570: 7.5X65 MONO-AXIAL REDUCTION PEDICLE SCREW
• 18257200058563: 7.5X60 MONO-AXIAL REDUCTION PEDICLE SCREW
• 18257200058556: 7.5X55 MONO-AXIAL REDUCTION PEDICLE SCREW
• 18257200058549: 7.5X50 MONO-AXIAL REDUCTION PEDICLE SCREW
• 18257200058532: 7.5X45 MONO-AXIAL REDUCTION PEDICLE SCREW
• 18257200058525: 7.5X40 MONO-AXIAL REDUCTION PEDICLE SCREW
• 18257200058518: 7.5X35 MONO-AXIAL REDUCTION PEDICLE SCREW
• 18257200058501: 7.5X30 MONO-AXIAL REDUCTION PEDICLE SCREW
• 18257200058495: 7.5X25 MONO-AXIAL REDUCTION PEDICLE SCREW
• 18257200058488: 6.5X80 MONO-AXIAL REDUCTION PEDICLE SCREW
• 18257200058471: 6.5X75 MONO-AXIAL REDUCTION PEDICLE SCREW
• 18257200058464: 6.5X70 MONO-AXIAL REDUCTION PEDICLE SCREW
• 18257200058457: 6.5X65 MONO-AXIAL REDUCTION PEDICLE SCREW
• 18257200058440: 6.5X60 MONO-AXIAL REDUCTION PEDICLE SCREW
• 18257200058433: 6.5X55 MONO-AXIAL REDUCTION PEDICLE SCREW
• 18257200058426: 6.5X50 MONO-AXIAL REDUCTION PEDICLE SCREW
• 18257200058419: 6.5X45 MONO-AXIAL REDUCTION PEDICLE SCREW
• 18257200058402: 6.5X40 MONO-AXIAL REDUCTION PEDICLE SCREW
• 18257200058396: 6.5X35 MONO-AXIAL REDUCTION PEDICLE SCREW
• 18257200058389: 6.5X30 MONO-AXIAL REDUCTION PEDICLE SCREW
• 18257200058372: 6.5X25 MONO-AXIAL REDUCTION PEDICLE SCREW
• 18257200058365: 5.5X75 MONO-AXIAL REDUCTION PEDICLE SCREW
• 18257200058358: 5.5X70 MONO-AXIAL REDUCTION PEDICLE SCREW
• 18257200058341: 5.5X65 MONO-AXIAL REDUCTION PEDICLE SCREW
• 18257200058334: 5.5X60 MONO-AXIAL REDUCTION PEDICLE SCREW
• 18257200058327: 5.5X55 MONO-AXIAL REDUCTION PEDICLE SCREW
• 18257200058310: 5.5X50 MONO-AXIAL REDUCTION PEDICLE SCREW
• 18257200058303: 5.5X45 MONO-AXIAL REDUCTION PEDICLE SCREW
• 18257200058297: 5.5X40 MONO-AXIAL REDUCTION PEDICLE SCREW
• 18257200058280: 5.5X35 MONO-AXIAL REDUCTION PEDICLE SCREW
• 18257200058273: 5.5X30 MONO-AXIAL REDUCTION PEDICLE SCREW
• 18257200058266: 5.5X25 MONO-AXIAL REDUCTION PEDICLE SCREW
• 18257200058259: 4.5X70 MONO-AXIAL REDUCTION PEDICLE SCREW
• 18257200058242: 4.5X65 MONO-AXIAL REDUCTION PEDICLE SCREW
• 18257200058235: 4.5X60 MONO-AXIAL REDUCTION PEDICLE SCREW