Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System— 510(k) K213328
Substantially EquivalentStryker GmbH
FDA 510(k) clearance K213328 for Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System, Substantially Equivalent on 2022-02-11. Applicant: Stryker GmbH. Device class: 2.
Clearance details
- Applicant
- Stryker 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
- Traditional
- Location
- Mahwah, NJ, US
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 GmbH
view all- K253640 — T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System
- K253202 — Hoffmann LRF System
- K251400 — T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing System
- K250163 — T2 Alpha Femur Retrograde Nailing System
- K242445 — Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea Tibia Plating 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 →
Recalls naming K213328
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K213328.
Data sourced from openFDA. This site is unofficial and independent of the FDA.