Data / Medical devices / United States / SIGN Fracture Care International

SIGN Fracture Care International: FDA-registered device maker in Richland, WA, United States, 7 510(k) clearances

Name: SIGN Fracture Care International FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

SIGN Fracture Care International is registered with the FDA (registration 3034525) in Richland, WA, United States. It lists 23 device types. The FDA files 7 510(k) clearances under its listings, the newest dated July 20, 2017. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3034525
FEI number: 3003356728
Address: 451 Hills St Ste B, Richland, WA, United States, 99354
Owner or operator: SIGN Fracture Care International (9045925)
Roles: Manufacturer, Specification developer
First device listed: May 3, 2001
Registered through: 2026
Brand names listed: 3.5mm Conical Washer, 3.5mm Hex Driver, Adjustment Screw, Alignment Pin, Angle Guide, Bit Adapter, Bone Mill Assembly, Bone Scoop and more

Devices it lists

Device	Product code	Class	Role	Source
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	KTT	2	Manufacturer	accessdata.fda.gov
Bender	HXW	1	Manufacturer	accessdata.fda.gov
Bit, Drill	HTW	1	Manufacturer	accessdata.fda.gov
Blade, Scalpel	GES	1	Specification developer	accessdata.fda.gov
Bone Mill	LYS	1	Manufacturer	accessdata.fda.gov
Broach	HTQ	1	Manufacturer	accessdata.fda.gov
Clamp, Surgical, General & Plastic Surgery	GDJ	1	Manufacturer	accessdata.fda.gov
Curette	HTF	1	Manufacturer	accessdata.fda.gov
Expander, Surgical, Skin Graft	FZW	1	Manufacturer	accessdata.fda.gov
Extractor	HWB	1	Manufacturer	accessdata.fda.gov
Gauge, Depth	HTJ	1	Manufacturer	accessdata.fda.gov
Guide, Surgical, Instrument	FZX	1	Manufacturer	accessdata.fda.gov
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	HWE	1	Manufacturer	accessdata.fda.gov
Orthopedic Manual Surgical Instrument	LXH	1	Manufacturer	accessdata.fda.gov
Plate, Fixation, Bone	HRS	2	Manufacturer	accessdata.fda.gov
Probe	HXB	1	Manufacturer	accessdata.fda.gov
Reamer	HTO	1	Manufacturer	accessdata.fda.gov
Rod, Fixation, Intramedullary And Accessories	HSB	2	Manufacturer	accessdata.fda.gov
Screw, Fixation, Bone	HWC	2	Manufacturer	accessdata.fda.gov
Screwdriver	HXX	1	Specification developer	accessdata.fda.gov
Template	HWT	1	Manufacturer	accessdata.fda.gov
Tray, Surgical, Instrument	FSM	1	Manufacturer	accessdata.fda.gov
Wrench	HXC	1	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
July 20, 2017	K163589	SIGN IM Nail	HSB	Substantially Equivalent	Sign Fracture Care International	accessdata.fda.gov
February 25, 2016	K153759	SIGN Compression Screw System	HWC	Substantially Equivalent	Sign Fracture Care International	accessdata.fda.gov
November 13, 2015	K152757	SIGN Hip Construct (SHC)	HSB	Substantially Equivalent	Sign Fracture Care International	accessdata.fda.gov
April 16, 2013	K122823	SIGN PEDIATRIC FIN NAIL	HSB	Substantially Equivalent	Sign Fracture Care International	accessdata.fda.gov
August 26, 2009	K083582	SIGN HIP CONSTRUCT (SHC), MODEL: 701	KTT	Substantially Equivalent	Surgical Implant Generation Network (Sign)	accessdata.fda.gov
February 3, 2005	K043200	SIGN FIN NAIL	HSB	Substantially Equivalent	Surgical Implant Generation Network (Sign)	accessdata.fda.gov
September 23, 2002	K022632	SIGN IM NAIL	HSB	Substantially Equivalent	Surgical Implant Generation Network (Sign)	accessdata.fda.gov

Compare with other makers

Updated July 20, 2017. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.