DUAL TAPER WEDGE PRESSED FIT FEMORAL COMPONENT— 510(k) K953268
Substantially EquivalentStelkast Company
FDA 510(k) clearance K953268 for DUAL TAPER WEDGE PRESSED FIT FEMORAL COMPONENT, Substantially Equivalent on 1996-01-17. Applicant: Stelkast Company. Device class: 2.
Clearance details
- Applicant
- Stelkast Company
- Product code
- Code LWJ
- Device class
- Class 2
- Regulation
- 21 CFR 888.3360
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Pittsburgh, PA, US
Recent devices under product code LWJ
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view all- K122883 — EXP TIBIAL INSERTS AND PATELLAR COMPONENTS FOR THE PROVEN GEN-FLEX TOTAL KNEE SYSTEM
- K122773 — CROSS-OVER ACETABULAR SHELL & LINER
- K094035 — EXP ACETABULAR LINER, MODELS SC3342 NON-HOODED 28MM, SC3343 HOODED 28MM
- K081458 — PROVEN STEM EXTENDER
- K063211 — PROVEN KNEE SYSTEM HIGH FLEXION TIBIAL INSERT
Adverse events under product code LWJ
product code LWJ- Injury
- 544
- Total
- 544
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.