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Gamma4 System
FDA 510(k)Class II (US FDA 510(k))
510(k) K230512
by Stryker GmbH
Identifiers
- 510(k) Number
- K230512 FDA 510(k)
- FDA Product Code
- HSB FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3020 FDA 510(k)
- Regulation Number
- 888.3020 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Gamma4 System is a highly advanced, FDA-registered orthopedic implant designed for precise and minimally invasive placement in the spine. Featuring a unique hybrid design that combines the benefits of both microsurgery and traditional orthopedic methods, this system offers unparalleled accuracy and stability. With its user-friendly interface and robust software package, the Gamma4 System has revolutionized the field of orthopedic surgery, providing clinicians with more precise control and improved patient outcomes.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K230512 | Class II | Active |
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Manufacturer
- Manufacturer
- Stryker GmbH
Sources (1)
- FDA 510(k) K230512 24 fields · synced Jul 9, 2026