Styrker OrthoMap Express Knee System— 510(k) K153240
Substantially EquivalentStryker Corporate
FDA 510(k) clearance K153240 for Styrker OrthoMap Express Knee System, Substantially Equivalent on 2016-07-07. Applicant: Stryker Corporate. Device class: 2.
Clearance details
- Applicant
- Stryker Corporate
- Product code
- Code OLO
- Device class
- Class 2
- Regulation
- 21 CFR 882.4560
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Freiburg, Baden-Wuerttemberg, DE
Recent devices under product code OLO
view allMore clearances from Stryker Corporate
view all- K143597 — Navigated XIA 4.5 Polyaxial Screwdriver
- K141941 — SPINEMASK TRACKER, SPINEMAP 3D 3.0-SOFTWARE,SPINEMAP 3D 3.0-UPGREADE, SPINEMAP 3D 3.0-ENABLE, SPINEMAP 3D 3.0-SALES D
- K141551 — PROFESS SOFTWARE, PROFESS CURVED 70 (DEGREES) SUCTION, PROFESS CURVED 70 (DEGREES) SUCTION, PROFESS CURVED 90 (DEGREES)
- K131214 — CRANIAL MAP NEURO
- K130874 — STRYKER NAV3I PLATFORM
Adverse events under product code OLO
product code OLO- Death
- 11
- Injury
- 2,799
- Malfunction
- 11,105
- Other
- 1
- Total
- 13,916
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.