SFS

GUDID 18257200057528

REDUCTION SCREW HEAD ADJUSTER REDUCTION PEDICLE SCREW

ORTHOFIX INC.

Bone-screw internal spinal fixation system, non-sterile

Primary Device ID	18257200057528
NIH Device Record Key	ef669cff-0874-4562-913a-44b81be4ddc4
Commercial Distribution Status	In Commercial Distribution
Brand Name	SFS
Version Model Number	59-0300
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	18257200057528 [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

[18257200057528]

Moist Heat or Steam Sterilization

[18257200057528]

Moist Heat or Steam Sterilization

[18257200057528]

Moist Heat or Steam Sterilization

[18257200057528]

Moist Heat or Steam Sterilization

[18257200057528]

Moist Heat or Steam Sterilization

[18257200057528]

Moist Heat or Steam Sterilization

[18257200057528]

Moist Heat or Steam Sterilization

[18257200057528]

Moist Heat or Steam Sterilization

[18257200057528]

Moist Heat or Steam Sterilization

[18257200057528]

Moist Heat or Steam Sterilization

[18257200057528]

Moist Heat or Steam Sterilization

[18257200057528]

Moist Heat or Steam Sterilization

[18257200057528]

Moist Heat or Steam Sterilization

[18257200057528]

Moist Heat or Steam Sterilization

[18257200057528]

Moist Heat or Steam Sterilization

[18257200057528]

Moist Heat or Steam Sterilization

[18257200057528]

Moist Heat or Steam Sterilization

[18257200057528]

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]

18257200131549	SFS Tray Kit, Case 1 Instruments and Implants (58-0010)
18257200082049	SFS CONSIGNMENT OPTION 1 W/ 56 SERIES PEDICLE SCREWS (56-0010)
18257200081493	SFS RED (59-0010)
18257200081462	SFS (56-0020)
18257200081455	SFS (58-0010)
18257200061129	4.0MM X 55MM MONO-AXIAL REDUCTION SCREW, STD
18257200061112	4.0MM X 50MM MONO-AXIAL REDUCTION SCREW, STD
18257200061105	4.0MM X 45MM MONO-AXIAL REDUCTION SCREW, STD
18257200061099	4.0MM X 40MM MONO-AXIAL REDUCTION SCREW, STD
18257200061082	4.0MM X 35MM MONO-AXIAL REDUCTION SCREW, STD
18257200061075	4.0MM X 30MM MONO-AXIAL REDUCTION SCREW, STD
18257200061068	4.0MM X 25MM MONO-AXIAL REDUCTION SCREW, STD
18257200061051	4.0MM X 110MM MONO-AXIAL REDUCTION SCREW, STD
18257200061044	4.0MM X 100MM MONO-AXIAL REDUCTION SCREW, STD
18257200057580	SFS REDUCTION SCREW CADDY
18257200057573	SFS REDUCTION SCREW SYSTEM STERILIZATION CASE
18257200057566	REDUCTION ROD CUTTER
18257200057559	MULTI-AXIAL REDUCTION SCREWDRIVER REDUCTION PEDICLE SCREW
18257200057542	MONO-AXIAL REDUCTION SCREWDRIVER REDUCTION PEDICLE SCREW
18257200057535	TAB REMOVAL TOOL REDUCTION PEDICLE SCREW
18257200057528	REDUCTION SCREW HEAD ADJUSTER REDUCTION PEDICLE SCREW
18257200057511	SCALLOPED ANTI SPLAY TOOL REDUCTION PEDICLE SCREW
18257200057504	ANTI SPLAY TOOL REDUCTION PEDICLE SCREW
18257200056538	24MM FIXED CROSS CONNECTOR
18257200056521	22MM FIXED CROSS CONNECTOR
18257200056514	20MM FIXED CROSS CONNECTOR
18257200056507	18MM FIXED CROSS CONNECTOR
18257200056491	16MM FIXED CROSS CONNECTOR
18257200056477	WIDE LUMBAR LAMINAR HOOK SFS HOOK SYSTEM
18257200056460	NARROW LUMBAR LAMINAR HOOK SFS HOOK SYSTEM
18257200056453	WIDE THORACIC LAMINAR HOOK SFS HOOK SYSTEM
18257200056446	NARROW THORACIC LAMINAR HOOK SFS HOOK SYSTEM
18257200056439	OFFSET RIGHT HOOK SFS HOOK SYSTEM
18257200056422	OFFSET LEFT HOOK SFS HOOK SYSTEM
18257200056415	ANGLED RIGHT HOOK SFS HOOK SYSTEM
18257200056408	ANGLED LEFT HOOK SFS HOOK SYSTEM
18257200056392	LARGE PEDICLE HOOK SFS HOOK SYSTEM
18257200056385	SMALL PEDICLE HOOK SFS HOOK SYSTEM
18257200056378	600MM ROD WITH HEX ENDS SFS HOOK SYSTEM
18257200056361	450MM ROD WITH HEX ENDS SFS HOOK SYSTEM
18257200056354	SET SCREW SFS HOOK SYSTEM
18257200056347	SCOLIOSIS INSTRUMENT CASE SFS HOOK SYSTEM #3
18257200056330	23 & 25MM X-CONNECTOR TEMPLATE
18257200056323	19 & 21MM X-CONNECTOR TEMPLATE
18257200056316	15 & 17MM X-CONNECTOR TEMPLATE
18257200056309	ROD CLAMP SFS HOOK SYSTEM
18257200056293	COMBINATION WRENCH, 5MM SFS HOOK SYSTEM
18257200056286	HOOK SET SCREW TORQUE T-HANDLE 80 LBS/IN, SFS HOOK SYSTEM
18257200056279	SET SCREW DRIVER/HOLDER SFS HOOK SYSTEM
18257200056262	BONE AWL SFS HOOK SYSTEM

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