T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws System, IMN Instruments System— 510(k) K191271
Substantially EquivalentStryker Trauma GmbH
FDA 510(k) clearance K191271 for T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws System, IMN Instruments System, Substantially Equivalent on 2019-06-11. Applicant: Stryker Trauma GmbH. Device class: 2.
Clearance details
- Applicant
- Stryker Trauma GmbH
- Product code
- Code HSB
- Device class
- Class 2
- Regulation
- 21 CFR 888.3020
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Schoenkirchen, DE
Recent devices under product code HSB
view all- K261481 — Pangea Femur Reconstruction System
- K253080 — AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)
- K261651 — Precice Max System and Precice Ankle Salvage System
- K253155 — Fule Metallic Lockable Intramedullary Nail Systems
- K253046 — HERA Interlocking Intramedullary Nailing System
More clearances from Stryker Trauma GmbH
view all- K200869 — Gamma3 System
- K193308 — T2 Alpha Tibia Nailing System, IMN Screws System
- K180436 — T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System
- K172774 — T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System
- K170418 — Stryker SonicPin System
Adverse events under product code HSB
product code HSB- Death
- 49
- Injury
- 12,083
- Malfunction
- 6,561
- Other
- 1
- Total
- 18,694
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.