FDA Registration
Active
🇺🇸 United States
SIGN Fracture Care International
Reg #: 3034525
·
FEI: 3003356728
·
Expires 2026
Products
23
Proprietary Names
63
Establishment Types
2
Classifications
23
Registration Details
- Registration Name
- SIGN Fracture Care International
- Registration Number
- 3034525
- FEI Number
- 3003356728
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 451 Hills St Ste B
- City
- RICHLAND
- State
- WA
- ZIP
- 99354
- Country
- US
Regulatory Submissions
- 510(k) Number
- K122823
Owner / Operator
- Firm Name
- SIGN Fracture Care International
- Operator Number
- 9045925
- Address
- 451 Hills Street, Suite B, --
- City
- Richland
- State
- WA
- Postal Code
- 99354
- Country
- US
- Correspondent
- Robert J Schmitt
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Extractor | HWB | Class 1 | Orthopedic | No | 2001-05-03 |
| Clamp, Surgical, General & Plastic Surgery | GDJ | Class 1 | General, Plastic Surgery | No | 2020-10-27 |
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2015-12-15 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2001-05-03 |
| Probe | HXB | Class 1 | Orthopedic | No | 2001-05-03 |
| Bone Mill | LYS | Class 1 | Orthopedic | No | 2019-05-08 |
| Bender | HXW | Class 1 | Orthopedic | No | 2009-09-01 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2006-03-22 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | Class 2 | Orthopedic | No | 2017-08-30 |
| Curette | HTF | Class 1 | General, Plastic Surgery | No | 2021-01-28 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2009-09-01 |
| Blade, Scalpel | GES | Class 1 | General, Plastic Surgery | No | 2025-12-09 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2019-05-08 |
| Wrench | HXC | Class 1 | Orthopedic | No | 2019-05-08 |
| Broach | HTQ | Class 1 | Orthopedic | No | 2019-05-08 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2001-05-03 |
| Template | HWT | Class 1 | Orthopedic | No | 2001-05-03 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2019-05-08 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2011-10-27 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2001-05-03 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2019-05-08 |
| Expander, Surgical, Skin Graft | FZW | Class 1 | General, Plastic Surgery | No | 2023-10-09 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2017-08-30 |
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
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
Pilot Reamer
Hand Reamer
Screw Caddy
Reamer Tray
Instrument Tray System
Skin Graft System Tray
Angle Guide
Pilot Drill
Drill Bit 6.3mm X 180mm
Drill Bit 3.5mm X 280mm
Step Drill
Mesher Top Plate
Dermatome Handle Assembly
Mesher Bottom Plate
Dermatome Cap Assembly
SIGN Compression Screw System
Establishment Types
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility