Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3034525

FEI Number

3003356728

Entity Name

SIGN Fracture Care International

City/State/Country

RICHLAND, WA, US

Establishment Address

451 Hills St Ste B, RICHLAND, WA 99354, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SIGN Fracture Care International (Owner Number: 9045925)

Owner / Operator Contact Address

451 Hills Street, Suite B, --, Richland, WA 99354, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Extractor Rod Connector Slap Hammer Weight Extractor-Compressor Rod Sliding Jaw Reduction Hook SIGN Pediatric Fin Nail SIGN Fin Nail Tissue Protector Cannulated Slot Finder Curved Slot Finder Solid Slot Finder Bone Mill Assembly Mill L-Handle Step Screw, Series IV Step Screw, Series V Locking Bolt HV Large Plate 3.5mm Conical Washer Fx Plate System Cortical Screw, 3.5mm SIGN IM Nail Plate Bender Depth Gauge SIGN IM Nail Adjustment Screw Distal Extension Shoulder Cap Screw Proximal Target Arm Cannula Alignment Pin Center Section Drill Guide Bone Scoop SIGN Hip Construct (SHC) Dermatome Blade Flute Scraper Drill Cover Drill Extension Assembly Drill Chuck Key Bit Adapter Open End Wrench Combination Hex Wrench Screw Hole Broach 3.5mm Hex Driver SHC X-Ray Template Pediatric Fin Nail X-Ray Template Elbow Plate Bending Template

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HWB	Extractor	Orthopedic	Class 1	888.4540	2001-05-03
GDJ	Clamp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2020-10-27
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2015-12-15
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2001-05-03
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2001-05-03
HXB	Probe	Orthopedic	Class 1	888.4540	2001-05-03
LYS	Bone Mill	Orthopedic	Class 1	888.4540	2019-05-08
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2001-05-03
HXW	Bender	Orthopedic	Class 1	888.4540	2009-09-01
HTJ	Gauge, Depth	Orthopedic	Class 1	888.4300	2006-03-22
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2017-08-30
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2017-08-30
HTF	Curette	General, Plastic Surgery	Class 1	878.4800	2021-01-28
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2009-09-01
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2009-09-01
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2009-09-01
GES	Blade, Scalpel	General, Plastic Surgery	Class 1	878.4800	2025-12-09
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2019-05-08
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2019-05-08
HXC	Wrench	Orthopedic	Class 1	888.4540	2019-05-08
HTQ	Broach	Orthopedic	Class 1	888.4540	2019-05-08
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2001-05-03
HWT	Template	Orthopedic	Class 1	888.4800	2001-05-03

Official Correspondent

Robert Schmitt

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SIGN Fracture Care International

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K040336	Synthes (Usa)	SYNTHES (USA) LATERAL ENTRY FEMORAL NAIL SYSTEM	2004-04-12
K083648	Efratgo, Ltd. HI Tech Bio-Surgical	GOTFRIED PHYSIOLOGICAL HIP (PH) NAIL	2009-05-14
K192312	Zimmer GmbH	Zimmer Natural Nail System Cephalomedullary Nails	2019-10-11
K002057	Biomet Orthopedics, Inc.	BROOKER TIBIA NAILS	2000-10-04
K033476	Howmedica Osteonics Corp.	MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM	2004-01-20

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2007	Smith & Nephew Inc	1	Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.
Z-0010-2007	Smith & Nephew Inc	1	Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486
Z-0011-06	Stryker Howmedica Osteonics Corp.	1	Allocraft TLIF Bone Inserter.
Z-0011-2007	Smith & Nephew Inc	1	Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105
Z-0013-2011	Depuy Orthopaedics, Inc.	1	Summit Broach Handle, NON-STERILE, MFG: DEPUY ORTHOPAEDICS, INC., PO BOX 988 WARSAW, IN 46581, 1 800 366 8143 Catalog Number: 2570-00-000 The Summit Broach Handle (instrumentation) is used with the DePuy Summit Tapered Hip System. The Broach Handle is used to prepare the femur for hip system implantation. The broach handle is an impaction/extraction device that holds broaches for creating the cavity in the femur during hip arthroplasty.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3034525. Last updated year: 2026. Please use registration number 3034525 when referencing this establishment in official correspondence.