AXSOS DISTAL LATERAL FEMUR TS LONG PLATES— 510(k) K122308
Substantially EquivalentHowmedica Osteonics Corp., Dba Stryker Orthopaedics
FDA 510(k) clearance K122308 for AXSOS DISTAL LATERAL FEMUR TS LONG PLATES, Substantially Equivalent on 2012-10-01. Applicant: Howmedica Osteonics Corp., Dba Stryker Orthopaedics. Device class: 2.
Clearance details
- Applicant
- Howmedica Osteonics Corp., Dba Stryker Orthopaedics
- Product code
- Code HRS
- Device class
- Class 2
- Regulation
- 21 CFR 888.3030
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Mahwah, NJ, US
Recent devices under product code HRS
view allMore clearances from Howmedica Osteonics Corp., Dba Stryker Orthopaedics
view all- K261898 — Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee System
- K261624 — Omnifit® 20° Series I Insert +11 more
- K253637 — Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert
- K252898 — Triathlon® Tritanium® Asymmetric Patella +5 more
- K252044 — Triathlon® Total Knee System - Triathlon® Gold Femoral Components
Adverse events under product code HRS
product code HRS- Death
- 27
- Injury
- 10,340
- Malfunction
- 3,328
- Total
- 13,695
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.