510(k) K213328
K213328 is an FDA 510(k) premarket notification submitted by Stryker GmbH for the device "Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System". The FDA issued a decision of Substantially Equivalent on Feb 11, 2022. The device falls under product code HSB (Rod, Fixation, Intramedullary And Accessories), a Class II device regulated under 21 CFR 888.3020. Stryker GmbH has 270 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 11, 2022
- Date Received
- Oct 5, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Rod, Fixation, Intramedullary And Accessories
- Device Class
- Class II
- Regulation Number
- 888.3020
- Review Panel
- OR
- Submission Type
- 510(k)