Gold Standard Orthopaedics, LLC
United StatesFDA applicant, unverified
- Devices
- 6
What Gold Standard Orthopaedics, LLC makes
Gold Standard Orthopaedics, LLC manufactures orthopaedic fixation devices, including bone screws, spinal systems, and cannulated screw systems designed for internal fixation in surgical procedures. Their product line includes spinal fixation hardware and bone fasteners used in trauma and orthopaedic reconstructions. These devices are intended for use in spinal and long-bone stabilization applications.
The company’s devices are classified as Class II under FDA regulations and are supported by 510(k) clearance records. Their products are listed in the FDA’s 510(k) database. The manufacturer is based in the United States.
Catalogue
Gso Bone Fixation Fasteners Ref K063589
Regimes: 510(k) Registry: 510(k)Gso ACP1 Anterior Cervical Plate System Ref K110990
Regimes: 510(k) Registry: 510(k)Gso GS1 Spacer Ref K071274
Regimes: 510(k) Registry: 510(k)Gso GS1 Cannulated Screw System Ref K123487
Regimes: 510(k) Registry: 510(k)Gso Pct Spinal System Ref K091359
Regimes: 510(k) Registry: 510(k)Gso GS1 Spinal System Ref K070966
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Gold Standard Orthopaedics, LLC have in the registry?
The registry currently lists 6 devices for Gold Standard Orthopaedics, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Gold Standard Orthopaedics, LLC's devices?
Among its 6 most recently registered devices, Gold Standard Orthopaedics, LLC has devices listed in FDA 510(k) (6 devices).
What risk classes do Gold Standard Orthopaedics, LLC's devices fall under?
Among its 6 most recently registered devices, the classes recorded for Gold Standard Orthopaedics, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Gold Standard Orthopaedics, LLC in the registry?
The most recently registered devices listed for Gold Standard Orthopaedics, LLC include GSO BONE FIXATION FASTENERS, GSO ACP1 ANTERIOR CERVICAL PLATE SYSTEM, GSO GS1 SPACER and GSO GS1 CANNULATED SCREW SYSTEM.