VARIAX ELBOW PLATING SYSTEM— 510(k) K141677
Substantially EquivalentStryker Trauma AG
FDA 510(k) clearance K141677 for VARIAX ELBOW PLATING SYSTEM, Substantially Equivalent on 2014-07-22. Applicant: Stryker Trauma AG. Device class: 2.
Clearance details
- Applicant
- Stryker Trauma AG
- 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
- Traditional
- Location
- Mahwah, NJ, US
Recent devices under product code HRS
view allMore clearances from Stryker Trauma AG
view all- K172210 — ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA)
- K153154 — Asnis JFX System
- K151178 — VariAx 2 Wrist Fusion System
- K143138 — AxSOS 3 Ti Locking Plate System
- K140961 — HOFFMANN LRF (LIMB RECONSTRUCTION FRAME) SYSTEM
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.