SIGN Fracture Care International
United Statesfrom the FDA registration address FDA establishment FEI 3003356728
- Devices
- 4
- Registrations
- FDA
- FDA recalls
- 0
What SIGN Fracture Care International makes
The company manufactures orthopedic fixation devices for fracture stabilization, including intramedullary nails for long bones (such as the femur and tibia), a modular hip construct system for complex pelvic or proximal femoral fractures, and compression screws for internal fixation. Their pediatric-specific intramedullary nail is designed for children’s long bone fractures, while the compression screw system is intended for stabilizing bone fragments in traumatic or surgical cases.
All listed devices fall under FDA Class II regulation and are authorised through the 510(k) clearance pathway. The company is based in the United States, with its products registered in the FDA’s 510(k) database. No additional international regulatory listings are referenced in the provided data.
Catalogue
SIGN IM Nail Ref K163589
Regimes: 510(k) Registry: 510(k)SIGN Hip Construct (SHC) Ref K152757
Regimes: 510(k) Registry: 510(k)SIGN Compression Screw System Ref K153759
Regimes: 510(k) Registry: 510(k)Sign Pediatric Fin Nail Ref K122823
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3003356728
- Address
- 451 Hills St Ste B, RICHLAND, WA, 99354
Frequently asked questions
How many devices does SIGN Fracture Care International have in the registry?
The registry currently lists 4 devices for SIGN Fracture Care International. Devices recorded under merged duplicate company entries are counted once.
Which registries list SIGN Fracture Care International's devices?
Among its 4 most recently registered devices, SIGN Fracture Care International has devices listed in FDA 510(k) (4 devices).
What risk classes do SIGN Fracture Care International's devices fall under?
Among its 4 most recently registered devices, the classes recorded for SIGN Fracture Care International's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from SIGN Fracture Care International in the registry?
The most recently registered devices listed for SIGN Fracture Care International include SIGN IM Nail, SIGN Hip Construct (SHC), SIGN Compression Screw System and SIGN PEDIATRIC FIN NAIL.