T2 Tibial Nailing System, T2 Femoral Nail System, T2 Supracondylar Nail System, T2 Recon Nail System, T2 Greater Trochanter Nail (GTN),T2 Ankle Arthrodesis Nail,T2 Arthrodesis Nail System— 510(k) K200880
Substantially EquivalentStryker GmbH
FDA 510(k) clearance K200880 for T2 Tibial Nailing System, T2 Femoral Nail System, T2 Supracondylar Nail System, T2 Recon Nail System, T2 Greater Trochanter Nail (GTN),T2 Ankle Arthrodesis Nail,T2 Arthrodesis Nail System, Substantially Equivalent on 2020-07-01. Applicant: Stryker GmbH. Device class: 2.
Clearance details
- Applicant
- Stryker GmbH
- Product code
- Product 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 allMore 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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.