Smith & Nephew, Inc., Orthopaedic Div.
United StatesFDA applicant, unverified
- Devices
- 10
What Smith & Nephew, Inc., Orthopaedic Div. makes
Smith & Nephew’s Orthopaedic Division manufactures external fixation systems, including the Taylor Spatial Frame and Heidelberg External Fixator, for fracture stabilization. Their portfolio also includes acetabular components like the Opera Cupflanged system, hip stems (e.g., HA Global Taper and Spectron Titanium), and tibial inserts (e.g., ProFix Plus variants). Spinal solutions include titanium rod systems and plating (e.g., Ultium Spinal Plating), alongside ceramic femoral heads (e.g., Zirconia ProZyr) and universal joint hinges (e.g., Compass).
These devices are classified as Class II under FDA regulations and are supported by 510(k) clearances. The manufacturer is based in the United States.
Catalogue
Taylor Spatial Frame External Fixation System Ref K970748
Regimes: 510(k) Registry: 510(k)Heidelberg External Fixator Ref K970751
Regimes: 510(k) Registry: 510(k)Opera Cupflanged Acetabular Components Ref K991538
Regimes: 510(k) Registry: 510(k)Titanium Spinal Rod System Ref K970635
Regimes: 510(k) Registry: 510(k)Ha Global Taper (Gt) Tapered Hip Stem Ref K970337
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Global Taper Spectron Hip Stems Ref K970351
Regimes: 510(k) Registry: 510(k)Compass Universal Hinge Ref K970713
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Ultium Spinal Plating System Ref K962784
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Smith & Nephew, Inc., Orthopaedic Div. have in the registry?
The registry currently lists 10 devices for Smith & Nephew, Inc., Orthopaedic Div.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Smith & Nephew, Inc., Orthopaedic Div.'s devices?
Among its 10 most recently registered devices, Smith & Nephew, Inc., Orthopaedic Div. has devices listed in FDA 510(k) (10 devices).
What risk classes do Smith & Nephew, Inc., Orthopaedic Div.'s devices fall under?
Among its 10 most recently registered devices, the classes recorded for Smith & Nephew, Inc., Orthopaedic Div.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Smith & Nephew, Inc., Orthopaedic Div. in the registry?
The most recently registered devices listed for Smith & Nephew, Inc., Orthopaedic Div. include TAYLOR SPATIAL FRAME EXTERNAL FIXATION SYSTEM, HEIDELBERG EXTERNAL FIXATOR, OPERA CUPFLANGED ACETABULAR COMPONENTS and TITANIUM SPINAL ROD SYSTEM.