Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System
FDA 510(k) clearance K213328 · decided 2022-02-11
Clearance details
- K-number
- K213328
- Device name
- Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System
- Applicant
- Stryker GmbH
- Decision
- Substantially Equivalent
- Date received
- 2021-10-05
- Decision date
- 2022-02-11
- Days to decision
- 129 days
- Clearance type
- Traditional
- Product code
- HSB
- Device class
- 2
- Regulation number
- 888.3020
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Mahwah, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System. Catalog Number: 84 recall (Z-1914-2025) | Stryker GmbH | 2025-06-06 |