EXP ACETABULAR LINER, MODELS SC3342 NON-HOODED 28MM, SC3343 HOODED 28MM— 510(k) K094035
Substantially EquivalentStelkast Company
FDA 510(k) clearance K094035 for EXP ACETABULAR LINER, MODELS SC3342 NON-HOODED 28MM, SC3343 HOODED 28MM, Substantially Equivalent on 2011-03-24. Applicant: Stelkast Company.
Clearance details
- Applicant
- Stelkast Company
- Product code
- Code OQG
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mcmurray, PA, US
Adverse events under product code OQG
product code OQG- Injury
- 249
- Total
- 249
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.